Percutaneous coronary intervention (pci) planning interface and associated devices, systems, and methods

ABSTRACT

A method of evaluating a vessel of a patient is provided. The method includes outputting, to a display device, a screen display including: a visualization based on pressure measurements obtained from a first instrument and a second instrument positioned within the vessel of the patient while the second instrument is moved longitudinally through the vessel and the first instrument remains stationary within the vessel; and a visual representation of a vessel; receiving a user input to modify the visualization to simulate a therapeutic procedure; and updating the screen display, in response to the user input, including modifying the visualization based on the user input. A system for evaluating a vessel of a patient is also provided. The system includes first and second instruments sized and shaped for introduction into the vessel of the patient; and a processing system communicatively coupled to the first and second instruments and a display device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.14/939,172, filed Nov. 12, 2015, now U.S. Pat. No. 10,667,775, whichclaims priority to and the benefit of the U.S. Provisional PatentApplication No. 62/080,023, filed Nov. 14, 2014, each of which is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to the assessment of vesselsfor percutaneous coronary intervention (PCI) planning. For example, someembodiments of the present disclosure are suited for determiningphysiologic parameters for the PCI, such as stent position, stentlength, stent diameter, etc., by visualizing and varying the propertiesof a graphical representation of a stent positioned within a vesselusing a graphical user interface.

BACKGROUND

Innovations in diagnosing and verifying the level of success oftreatment of disease have progressed from solely external imagingprocesses to include internal diagnostic processes. In addition totraditional external image techniques such as X-ray, Mill, CT scans,fluoroscopy, and angiography, small sensors may now be placed directlyin the body. For example, diagnostic equipment and processes have beendeveloped for diagnosing vasculature blockages and other vasculaturedisease by means of ultra-miniature sensors placed upon the distal endof a flexible elongate member such as a catheter, or a guide wire usedfor catheterization procedures. For example, known medical sensingtechniques include intravascular ultrasound (IVUS), forward looking IVUS(FL-IVUS), fractional flow reserve (FFR) determination, a coronary flowreserve (CFR) determination, optical coherence tomography (OCT),trans-esophageal echocardiography, and image-guided therapy.

One exemplary type of procedure involves pressure measurements within ablood vessel. A currently accepted technique for assessing the severityof a stenosis in the blood vessel, including ischemia causing lesions,is fractional flow reserve (FFR). FFR is a calculation of the ratio of adistal pressure measurement (taken on the distal side of the stenosis)relative to a proximal pressure measurement (taken on the proximal sideof the stenosis). FFR provides an index of stenosis severity that allowsdetermination as to whether the blockage limits blood flow within thevessel to an extent that treatment is required. The normal value of FFRin a healthy vessel is 1.00, while values less than about 0.80 aregenerally deemed significant and require treatment. Another techniquefor assessing blood vessels utilizes Instant Wave-Free Ratio™Functionality (iFR® Functionality) (both trademarks of Volcano Corp.),which includes the determination of a pressure ratio across a stenosisduring the wave-free period, when resistance is naturally constant andminimized in the cardiac cycle. The iFR modality does not requireadministration of a hyperemic agent. The normal value of iFR in ahealthy vessel is 1.00, while values less than about 0.89 are generallydeemed significant and require treatment.

When an occluded blood vessel that requires treatment is identified, apercutaneous coronary intervention (PCI) is a therapeutic procedure thatcan be utilized to treat the vessel. A PCI includes angioplasty andpositioning a stent across the stenosis to open the vessel. Cliniciansconventionally rely on angiography and physiologic measurements ofpressure and/or flow, which are not meaningfully connected, to plan atherapeutic intervention. Planning the therapeutic intervention caninclude selecting various parameters related to the stent, such aspositioning, length, diameter, etc. Because it is difficult to integratethe various sources of data, there is difficulty in developing thetherapeutic plan. Further, there is little ability to predict theefficacy of the therapeutic intervention based on the available data.For example, a clinician conventionally cannot determine, with aclinical certainty that is supported by the collected data, what theeffect of changing the positioning and/or length of a stent is on theefficacy of the stent placement.

Accordingly, there remains a need for improved devices, systems, andmethods for assessing the severity of a blockage in a vessel and, inparticular, a stenosis in a blood vessel. There also remains a need forimproved devices, systems, and methods for planning a PCI by connectingthe angiography and physiologic data in a way that allows clinicians toefficiently plan and evaluate the proposed therapy. Further, thereremains a need for providing visual depictions of a vessel and aproposed therapeutic intervention, such as a stent, in the vessel thatallow a clinician to plan, evaluate, and change the proposed therapy ina manner supported by the collected physiologic data.

SUMMARY

Embodiments of the present disclosure are configured to provide agraphical user interface that illustrates a stent positioned within ablood vessel to allow a doctor to effectively plan a surgical procedureknown as a percutaneous coronary intervention (PCI). The position andlength of the stent within the blood vessel can be changed based on userinput. The image of the blood vessel can include various annotationsthat assist the doctor, including pressure ratio(s) calculated along thevessel's length, locations along the vessel associated with pressureratio(s), and the name of the vessel. In some embodiments, a menu ofstents is provided to a doctor such that the doctor can select a stentthat is in stock and available for use at the hospital while planningthe surgical procedure.

In an exemplary embodiment, a method of evaluating a vessel of a patientare provided. The method includes outputting, to a display device, ascreen display including: a visualization based on pressure measurementsobtained from a first instrument and a second instrument positionedwithin the vessel of the patient while the second instrument is movedlongitudinally through the vessel and the first instrument remainsstationary within the vessel; and a visual representation of a vessel;receiving a user input to modify the visualization to simulate atherapeutic procedure; and updating the screen display, in response tothe user input, including modifying the visualization based on the userinput.

In some embodiments, the method further includes obtaining angiographydata simultaneously as obtaining the pressure measurements, wherein thevisual representation of the vessel includes an angiographic image ofthe vessel, and wherein the visualization includes a graphical overlayon the angiographic image. In some embodiments, obtaining the pressuremeasurements includes moving the second instrument at a constant or anon-constant speed through the vessel. In some embodiments, thevisualization includes a graphical representation of a stent positionedin the visual representation of the vessel, and wherein the therapeuticprocedure is a percutaneous coronary intervention. In some embodiments,the method further includes determining physiological parameters for astent to be deployed in the vessel based on the characteristics of thegraphical representation of the stent. In some embodiments, thephysiological parameters include at least one of stent position, stentlength, and stent diameter; and the characteristics of the graphicalrepresentation of the stent include at least one of position, length,and diameter.

In some embodiments, the method further includes automaticallycalculating at least one of the stent length and the length of thegraphical representation of the stent based on at least one of theangiography data, the obtained pressure measurements, and a pressureratio calculated based on the obtained pressure measurements, whereinthe visualization includes a graphical representation of a stent havingthe calculated length. In some embodiments, the method further includesdetermining at least one of the stent length and the length of thegraphical representation of the stent based on the user input, whereinthe visualization includes a graphical representation of a stent havingthe determined length. In some embodiments, the method further includesdetermining at least one of the stent diameter and the diameter of thegraphical representation of the stent based on at least one of theangiography data and intravascular imaging data obtained within thevessel. In some embodiments, receiving a user input includes receiving auser input to move the graphical representation of the stent within thevisual representation of the vessel, and wherein modifying thevisualization includes outputting the graphical representation of thestent at the position based on the user input. In some embodiments,receiving a user input includes receiving a user input to change thelength of the graphical representation of the stent within the visualrepresentation of the vessel, and wherein modifying the visualizationincludes outputting the graphical representation of the stent with thelength based on the received user input.

In some embodiments, the method further includes outputting a pluralityof graphical representations of stents. In some embodiments, the methodfurther includes compiling the plurality of graphical representations ofstents based on an inventory database of stents associated with aclinical environment. In some embodiments, the method further includesat least one of: receiving a user input to select one of the pluralityof graphical representations of stents, wherein the visualizationincludes the selected graphical representation of a stent positioned inthe visual representation of the vessel; and automatically selecting agraphical representation of a stent from among a plurality of graphicalrepresentations of stents based on at least one of the angiography data,the obtained pressure measurements, and a pressure ratio calculatedbased on the obtained pressure measurements, wherein the visualizationincludes the automatically selected graphical representation of a stentfrom among the plurality of graphical representations of stents.

In some embodiments, the method further includes calculating a pressureratio within the vessel based on the obtained pressure measurements, andwherein the visualization further includes the calculated pressureratio. In some embodiments, the visualization further includes at leastone of: a marker indicative of a location within the vessel associatedwith the obtained pressure measurements; and the calculated pressureratio positioned adjacent to the marker indicative of the locationwithin the vessel. In some embodiments, the method further includesautomatically identifying the vessel, and wherein the visualizationfurther includes a label indicative of the determined identity of thevessel.

In another exemplary embodiment, a system for evaluating a vessel of apatient is provided. The system includes a first instrument sized andshaped for introduction into the vessel of the patient; a secondinstrument sized and shaped for introduction into the vessel of thepatient; and a processing system communicatively coupled to the firstand second instruments and a display device, the processing systemconfigured to: receive pressure measurements from the first instrumentand the second instrument positioned within the vessel of the patientwhile the second instrument is moved longitudinally through the vesseland the first instrument remains stationary within the vessel; output,to the display device, a screen display including: a visualization basedon pressure measurements received from the first instrument and thesecond instrument; and a visual representation of a vessel; receive auser input to modify the visualization to simulate a therapeuticprocedure; and update the screen display, in response to the user input,including modifying the visualization based on the user input.

In some embodiments, the visual representation of the vessel includes anangiographic image of the vessel, and wherein the visualization includesa graphical overlay on the angiographic image. In some embodiments, thevisualization includes a graphical representation of a stent positionedin the visual representation of the vessel, and wherein the therapeuticprocedure is a percutaneous coronary intervention. In some embodiments,the processing system is further configured to: determine physiologicalparameters for a stent to be deployed in the vessel based on thecharacteristics of the graphical representation of the stent. In someembodiments, the physiological parameters include at least one of stentposition, stent length, and stent diameter; and the characteristics ofthe graphical representation of the stent include at least one ofposition, length, and diameter.

In some embodiments, the processing system is further configured toautomatically calculate at least one of the stent length and the lengthof the graphical representation of the stent based on at least one ofthe angiography data, the received pressure measurements, and a pressureratio calculated based on the received pressure measurements, whereinthe visualization includes a graphical representation of a stent havingthe calculated length. In some embodiments, the processing system isfurther configured to determine at least one of the stent length and thelength of the graphical representation of the stent based on the userinput, wherein the visualization includes a graphical representation ofa stent having the determined length.

In some embodiments, the processing system is further configured toautomatically calculate at least one of the stent diameter and thediameter of the graphical representation of the stent based on at leastone of angiography data and intravascular ultrasound (IVUS) data. Insome embodiments, the processing system is configured receive a userinput by receiving a user input to move the graphical representation ofthe stent within the visual representation of the vessel, and whereinthe processing system is configured to modify the visualization byoutputting the graphical representation of the stent at a location basedon the user input. In some embodiments, the processing system isconfigured receive a user input by receiving a user input to change alength of the graphical representation of the stent within the vessel,and wherein the processing system is configured to modify thevisualization by outputting the graphical representation of the stentwith the length based on the received user input.

In some embodiments, the processing system is further configured tooutput a plurality of graphical representations of stents. In someembodiments, the processing system is further configured to compile theplurality of graphical representations of stents based on an inventorydatabase of stents associated with a clinical environment. In someembodiments, the processing system is further configured to do at leastone of: receive a user input to select one of the plurality of graphicalrepresentations of stents, wherein the visualization includes theselected graphical representation of a stent from among the plurality ofgraphical representations of stents; and automatically select agraphical representation of a stent from among a plurality of graphicalrepresentations of stents based on at least one of the angiography data,the received pressure measurements, and a pressure ratio calculatedbased on the received pressure measurements, wherein the visualizationincludes the automatically selected graphical representation of a stentfrom among the plurality of graphical representations of stents.

In some embodiments, the processing system is further configured tocalculate a pressure ratio within the vessel based on the receivepressure measurements, and wherein the visualization further includesthe calculated pressure ratio. In some embodiments, the visualizationfurther includes at least one of: a marker indicative of a locationwithin the vessel associated with the obtained pressure measurements;the calculated pressure ratio positioned adjacent to the markerindicative of the location within the vessel. In some embodimentssuccessive markers are positioned along the visual representation of thevessel at unequally spaced intervals. In some embodiments, theprocessing system is further configured to automatically identify thevessel, and wherein the visualization further includes a labelindicative of the determined identity of the vessel.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a diagrammatic perspective view of a vessel having a stenosisaccording to an embodiment of the present disclosure.

FIG. 2 is a diagrammatic, partial cross-sectional perspective view of aportion of the vessel of FIG. 1 taken along section line 2-2 of FIG. 1.

FIG. 3 is a diagrammatic, partial cross-sectional perspective view ofthe vessel of FIGS. 1 and 2 with instruments positioned thereinaccording to an embodiment of the present disclosure.

FIG. 4 is a diagrammatic, schematic view of a system according to anembodiment of the present disclosure.

FIG. 5 is a flow diagram of a method of evaluating a vessel of a patientaccording to an embodiment of the present disclosure.

FIG. 6 is a flow diagram of a method of evaluating a vessel of a patientaccording to another embodiment of the present disclosure.

FIG. 7 is a screen display according to an embodiment of the presentdisclosure.

FIG. 8a is a screen display according to another embodiment of thepresent disclosure.

FIG. 8b is a screen display according to another embodiment of thepresent disclosure.

FIG. 9 is a screen display according to another embodiment of thepresent disclosure.

FIG. 10 is a screen display according to another embodiment of thepresent disclosure.

FIG. 11 is a screen display according to another embodiment of thepresent disclosure.

FIG. 12 is a screen display according to another embodiment of thepresent disclosure.

FIG. 13 is a screen display according to another embodiment of thepresent disclosure.

FIG. 14 is a screen display according to another embodiment of thepresent disclosure.

FIG. 15 is a screen display according to another embodiment of thepresent disclosure.

FIG. 16 is a screen display according to another embodiment of thepresent disclosure.

FIG. 17 is a screen display according to another embodiment of thepresent disclosure.

FIG. 18 is a screen display according to another embodiment of thepresent disclosure.

FIG. 19 is a screen display according to another embodiment of thepresent disclosure.

FIG. 20 is a screen display according to another embodiment of thepresent disclosure.

FIG. 21 is a screen display according to another embodiment of thepresent disclosure.

FIG. 22 is a screen display according to another embodiment of thepresent disclosure.

FIG. 23 is a screen display according to another embodiment of thepresent disclosure.

FIG. 24 is a screen display according to another embodiment of thepresent disclosure.

FIG. 25 is a screen display according to another embodiment of thepresent disclosure.

FIG. 26 is a screen display according to another embodiment of thepresent disclosure.

FIG. 27 is a screen display according to another embodiment of thepresent disclosure.

FIG. 28 is a screen display according to another embodiment of thepresent disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates. In particular, it is fully contemplated that the features,components, and/or steps described with respect to one embodiment may becombined with the features, components, and/or steps described withrespect to other embodiments of the present disclosure. For the sake ofbrevity, however, the numerous iterations of these combinations will notbe described separately.

Referring to FIGS. 1 and 2, shown therein is a vessel 100 having astenosis according to an embodiment of the present disclosure. In thatregard, FIG. 1 is a diagrammatic perspective view of the vessel 100,while FIG. 2 is a partial cross-sectional perspective view of a portionof the vessel 100 taken along section line 2-2 of FIG. 1. Referring morespecifically to FIG. 1, the vessel 100 includes a proximal portion 102and a distal portion 104. A lumen 106 extends along the length of thevessel 100 between the proximal portion 102 and the distal portion 104.In that regard, the lumen 106 is configured to allow the flow of fluidthrough the vessel. In some instances, the vessel 100 is a blood vessel.In some particular instances, the vessel 100 is a coronary artery. Insuch instances, the lumen 106 is configured to facilitate the flow ofblood through the vessel 100.

As shown, the vessel 100 includes a stenosis 108 between the proximalportion 102 and the distal portion 104. Stenosis 108 is generallyrepresentative of any blockage or other structural arrangement thatresults in a restriction to the flow of fluid through the lumen 106 ofthe vessel 100. Embodiments of the present disclosure are suitable foruse in a wide variety of vascular applications, including withoutlimitation coronary, peripheral (including but not limited to lowerlimb, carotid, and neurovascular), renal, and/or venous. Where thevessel 100 is a blood vessel, the stenosis 108 may be a result of plaquebuildup, including without limitation plaque components such as fibrous,fibro-lipidic (fibro fatty), necrotic core, calcified (dense calcium),blood, fresh thrombus, and mature thrombus. Generally, the compositionof the stenosis will depend on the type of vessel being evaluated. Inthat regard, it is understood that the concepts of the presentdisclosure are applicable to virtually any type of blockage or othernarrowing of a vessel that results in decreased fluid flow.

Referring more particularly to FIG. 2, the lumen 106 of the vessel 100has a diameter 110 proximal of the stenosis 108 and a diameter 112distal of the stenosis. In some instances, the diameters 110 and 112 aresubstantially equal to one another. In that regard, the diameters 110and 112 are intended to represent healthy portions, or at leasthealthier portions, of the lumen 106 in comparison to stenosis 108.Accordingly, these healthier portions of the lumen 106 are illustratedas having a substantially constant cylindrical profile and, as a result,the height or width of the lumen has been referred to as a diameter.However, it is understood that in many instances these portions of thelumen 106 will also have plaque buildup, a non-symmetric profile, and/orother irregularities, but to a lesser extent than stenosis 108 and,therefore, will not have a cylindrical profile. In such instances, thediameters 110 and 112 are understood to be representative of a relativesize or cross-sectional area of the lumen and do not imply a circularcross-sectional profile.

As shown in FIG. 2, stenosis 108 includes plaque buildup 114 thatnarrows the lumen 106 of the vessel 100. In some instances, the plaquebuildup 114 does not have a uniform or symmetrical profile, makingangiographic evaluation of such a stenosis unreliable. In theillustrated embodiment, the plaque buildup 114 includes an upper portion116 and an opposing lower portion 118. In that regard, the lower portion118 has an increased thickness relative to the upper portion 116 thatresults in a non-symmetrical and non-uniform profile relative to theportions of the lumen proximal and distal of the stenosis 108. As shown,the plaque buildup 114 decreases the available space for fluid to flowthrough the lumen 106. In particular, the cross-sectional area of thelumen 106 is decreased by the plaque buildup 114. At the narrowest pointbetween the upper and lower portions 116, 118 the lumen 106 has a height120, which is representative of a reduced size or cross-sectional arearelative to the diameters 110 and 112 proximal and distal of thestenosis 108. Note that the stenosis 108, including plaque buildup 114is exemplary in nature and should be considered limiting in any way. Inthat regard, it is understood that the stenosis 108 has other shapesand/or compositions that limit the flow of fluid through the lumen 106in other instances. While the vessel 100 is illustrated in FIGS. 1 and 2as having a single stenosis 108 and the description of the embodimentsbelow is primarily made in the context of a single stenosis, it isnevertheless understood that the devices, systems, and methods describedherein have similar application for a vessel having multiple stenosisregions.

Referring now to FIG. 3, the vessel 100 is shown with instruments 130and 132 positioned therein according to an embodiment of the presentdisclosure. In general, instruments 130 and 132 may be any form ofdevice, instrument, or probe sized and shaped to be positioned within avessel. In the illustrated embodiment, instrument 130 is generallyrepresentative of a guide wire, while instrument 132 is generallyrepresentative of a catheter. In that regard, instrument 130 extendsthrough a central lumen of instrument 132. However, in otherembodiments, the instruments 130 and 132 take other forms. In thatregard, the instruments 130 and 132 are of similar form in someembodiments. For example, in some instances, both instruments 130 and132 are guide wires. In other instances, both instruments 130 and 132are catheters. On the other hand, the instruments 130 and 132 are ofdifferent form in some embodiments, such as the illustrated embodiment,where one of the instruments is a catheter and the other is a guidewire. Further, in some instances, the instruments 130 and 132 aredisposed coaxial with one another, as shown in the illustratedembodiment of FIG. 3. In other instances, one of the instruments extendsthrough an off-center lumen of the other instrument. In yet otherinstances, the instruments 130 and 132 extend side-by-side. In someparticular embodiments, at least one of the instruments is as arapid-exchange device, such as a rapid-exchange catheter. In suchembodiments, the other instrument is a buddy wire or other deviceconfigured to facilitate the introduction and removal of therapid-exchange device. Further still, in other instances, instead of twoseparate instruments 130 and 132 a single instrument is utilized. Insome embodiments, the single instrument incorporates aspects of thefunctionalities (e.g., data acquisition) of both instruments 130 and132.

Instrument 130 is configured to obtain diagnostic information about thevessel 100. In that regard, the instrument 130 includes one or moresensors, transducers, and/or other monitoring elements configured toobtain the diagnostic information about the vessel. The diagnosticinformation includes one or more of pressure, flow (velocity and/orvolume), images (including images obtained using ultrasound (e.g.,IVUS), OCT, thermal, and/or other imaging techniques), temperature,and/or combinations thereof. The one or more sensors, transducers,and/or other monitoring elements are positioned adjacent a distalportion of the instrument 130 in some instances. In that regard, the oneor more sensors, transducers, and/or other monitoring elements arepositioned less than 30 cm, less than 10 cm, less than 5 cm, less than 3cm, less than 2 cm, and/or less than 1 cm from a distal tip 134 of theinstrument 130 in some instances. In some instances, at least one of theone or more sensors, transducers, and/or other monitoring elements ispositioned at the distal tip of the instrument 130.

The instrument 130 includes at least one element configured to monitorpressure within the vessel 100. The pressure monitoring element can takethe form a piezo-resistive pressure sensor, a piezo-electric pressuresensor, a capacitive pressure sensor, an electromagnetic pressuresensor, a fluid column (the fluid column being in communication with afluid column sensor that is separate from the instrument and/orpositioned at a portion of the instrument proximal of the fluid column),an optical pressure sensor, and/or combinations thereof. In someinstances, one or more features of the pressure monitoring element areimplemented as a solid-state component manufactured using semiconductorand/or other suitable manufacturing techniques. Examples of commerciallyavailable guide wire products that include suitable pressure monitoringelements include, without limitation, the Verrata® pressure guide wire,the PrimeWire Prestige® PLUS pressure guide wire, and the ComboWire® XTpressure and flow guide wire, each available from Volcano Corporation,as well as the PressureWire′ Certus guide wire and the PressureWire′Aeris guide wire, each available from St. Jude Medical, Inc. Generally,the instrument 130 is sized such that it can be positioned through thestenosis 108 without significantly impacting fluid flow across thestenosis, which would impact the distal pressure reading. Accordingly,in some instances the instrument 130 has an outer diameter of 0.018″ orless. In some embodiments, the instrument 130 has an outer diameter of0.014″ or less. In some embodiments, the instrument 130 has an outerdiameter of 0.035″ or less.

Instrument 132 is also configured to obtain diagnostic information aboutthe vessel 100. In some instances, instrument 132 is configured toobtain the same diagnostic information as instrument 130. In otherinstances, instrument 132 is configured to obtain different diagnosticinformation than instrument 130, which may include additional diagnosticinformation, less diagnostic information, and/or alternative diagnosticinformation. The diagnostic information obtained by instrument 132includes one or more of pressure, flow (velocity and/or volume), images(including images obtained using ultrasound (e.g., IVUS), OCT, thermal,and/or other imaging techniques), temperature, and/or combinationsthereof. Instrument 132 includes one or more sensors, transducers,and/or other monitoring elements configured to obtain this diagnosticinformation. In that regard, the one or more sensors, transducers,and/or other monitoring elements are positioned adjacent a distalportion of the instrument 132 in some instances. In that regard, the oneor more sensors, transducers, and/or other monitoring elements arepositioned less than 30 cm, less than 10 cm, less than 5 cm, less than 3cm, less than 2 cm, and/or less than 1 cm from a distal tip 136 of theinstrument 132 in some instances. In some instances, at least one of theone or more sensors, transducers, and/or other monitoring elements ispositioned at the distal tip of the instrument 132.

Similar to instrument 130, instrument 132 also includes at least oneelement configured to monitor pressure within the vessel 100. Thepressure monitoring element can take the form a piezo-resistive pressuresensor, a piezo-electric pressure sensor, a capacitive pressure sensor,an electromagnetic pressure sensor, a fluid column (the fluid columnbeing in communication with a fluid column sensor that is separate fromthe instrument and/or positioned at a portion of the instrument proximalof the fluid column), an optical pressure sensor, and/or combinationsthereof. In some instances, one or more features of the pressuremonitoring element are implemented as a solid-state componentmanufactured using semiconductor and/or other suitable manufacturingtechniques. Currently available catheter products suitable for use withone or more of Siemens AXIOM Sensis, Mennen Horizon XVu, and PhilipsXper IM Physiomonitoring 5 and include pressure monitoring elements canbe utilized for instrument 132 in some instances.

In accordance with aspects of the present disclosure, at least one ofthe instruments 130 and 132 is configured to monitor a pressure withinthe vessel 100 distal of the stenosis 108 and at least one of theinstruments 130 and 132 is configured to monitor a pressure within thevessel proximal of the stenosis. In that regard, the instruments 130,132 are sized and shaped to allow positioning of the at least oneelement configured to monitor pressure within the vessel 100 to bepositioned proximal and/or distal of the stenosis 108 as necessary basedon the configuration of the devices. In that regard, FIG. 3 illustratesa position 138 suitable for measuring pressure distal of the stenosis108. In that regard, the position 138 is less than 5 cm, less than 3 cm,less than 2 cm, less than 1 cm, less than 5 mm, and/or less than 2.5 mmfrom the distal end of the stenosis 108 (as shown in FIG. 2) in someinstances. FIG. 3 also illustrates a plurality of suitable positions formeasuring pressure proximal of the stenosis 108. In that regard,positions 140, 142, 144, 146, and 148 each represent a position that issuitable for monitoring the pressure proximal of the stenosis in someinstances. In that regard, the positions 140, 142, 144, 146, and 148 arepositioned at varying distances from the proximal end of the stenosis108 ranging from more than 20 cm down to about 5 mm or less. Generally,the proximal pressure measurement will be spaced from the proximal endof the stenosis. Accordingly, in some instances, the proximal pressuremeasurement is taken at a distance equal to or greater than an innerdiameter of the lumen of the vessel from the proximal end of thestenosis. In the context of coronary artery pressure measurements, theproximal pressure measurement is generally taken at a position proximalof the stenosis and distal of the aorta, within a proximal portion ofthe vessel. However, in some particular instances of coronary arterypressure measurements, the proximal pressure measurement is taken from alocation inside the aorta. In other instances, the proximal pressuremeasurement is taken at the root or ostium of the coronary artery.

In some embodiments, at least one of the instruments 130 and 132 isconfigured to monitor pressure within the vessel 100 while being movedthrough the lumen 106. In some instances, instrument 130 is configuredto be moved through the lumen 106 and across the stenosis 108. In thatregard, the instrument 130 is positioned distal of the stenosis 108 andmoved proximally (i.e., pulled back) across the stenosis to a positionproximal of the stenosis in some instances. In other instances, theinstrument 130 is positioned proximal of the stenosis 108 and moveddistally across the stenosis to a position distal of the stenosis.Movement of the instrument 130, either proximally or distally, iscontrolled manually by medical personnel (e.g., hand of a surgeon) insome embodiments. In other embodiments, movement of the instrument 130,either proximally or distally, is controlled automatically by a movementcontrol device (e.g., a pullback device, such as the Trak Back® IIDevice available from Volcano Corporation). In that regard, the movementcontrol device controls the movement of the instrument 130 at aselectable and known speed (e.g., 2.0 mm/s, 1.0 mm/s, 0.5 mm/s, 0.2mm/s, etc.) in some instances. Movement of the instrument 130 throughthe vessel is continuous for each pullback or push through, in someinstances. In other instances, the instrument 130 is moved step-wisethrough the vessel (i.e., repeatedly moved a fixed amount of distanceand/or a fixed amount of time). Some aspects of the visual depictionsdiscussed below are particularly suited for embodiments where at leastone of the instruments 130 and 132 is moved through the lumen 106.Further, in some particular instances, aspects of the visual depictionsdiscussed below are particularly suited for embodiments where a singleinstrument is moved through the lumen 106, with or without the presenceof a second instrument.

The instruments 130 and/or 132 can be used to conduct medical sensingprocedures associated with Instant Wave-Free Ratio™ Functionality (iFR®Functionality) (both trademarks of Volcano Corp.) and those disclosed inU.S. patent application Ser. No. 13/460,296, entitled “DEVICES, SYSTEMS,AND METHODS FOR ASSESSING A VESSEL,” hereby incorporated by reference inits entirety, which discloses the use of pressure ratios that areavailable without application of a hyperemic agent. Further, medicalsensing procedures associated with compensated Pd/Pa ratios suitable forestimating iFR®, FFR, and/or other accepted diagnostic pressure ratiosas disclosed in U.S. Provisional Patent Application No. 62/024,005,filed Jul. 14, 2014 and entitled “DEVICES, SYSTEMS, AND METHODS FORTREATMENT OF VESSELS,” which is hereby incorporated by reference in itsentirety, can be conducted using the instruments 130 and/or 132.

Referring now to FIG. 4, shown therein is a system 150 according to anembodiment of the present disclosure. In that regard, FIG. 4 is adiagrammatic, schematic view of the system 150. As shown, the system 150includes an instrument 152. In that regard, in some instances instrument152 is suitable for use as at least one of instruments 130 and 132discussed above. Accordingly, in some instances the instrument 152includes features similar to those discussed above with respect toinstruments 130 and 132 in some instances. In the illustratedembodiment, the instrument 152 is a guide wire having a distal portion154 and a housing 156 positioned adjacent the distal portion. In thatregard, the housing 156 is spaced approximately 3 cm from a distal tipof the instrument 152. The housing 156 is configured to house one ormore sensors, transducers, and/or other monitoring elements configuredto obtain the diagnostic information about the vessel. In theillustrated embodiment, the housing 156 contains at least a pressuresensor configured to monitor a pressure within a lumen in which theinstrument 152 is positioned. A shaft 158 extends proximally from thehousing 156. A torque device 160 is positioned over and coupled to aproximal portion of the shaft 158. A proximal end portion 162 of theinstrument 152 is coupled to a connector 164. A cable 166 extends fromconnector 164 to a connector 168. In some instances, connector 168 isconfigured to be plugged into an interface 170. In that regard,interface 170 is a patient interface module (PIM) in some instances. Insome instances, the cable 166 is replaced with a wireless connection. Inthat regard, it is understood that various communication pathwaysbetween the instrument 152 and the interface 170 may be utilized,including physical connections (including electrical, optical, and/orfluid connections), wireless connections, and/or combinations thereof.

The interface 170 is communicatively coupled to a computing device 172via a connection 174. Computing device 172 is generally representativeof any device suitable for performing the processing and analysistechniques discussed within the present disclosure. In some embodiments,the computing device 172 includes a processor, random access memory, anda storage medium. In that regard, in some particular instances thecomputing device 172 is programmed to execute steps associated with thedata acquisition and analysis described herein. Accordingly, it isunderstood that any steps related to data acquisition, data processing,instrument control, and/or other processing or control aspects of thepresent disclosure may be implemented by the computing device usingcorresponding instructions stored on or in a non-transitory computerreadable medium accessible by the computing device. In some instances,the computing device 172 is a console device. In some particularinstances, the computing device 172 is similar to the s5™ Imaging Systemor the s5i® Imaging System, each available from Volcano Corporation. Insome instances, the computing device 172 is portable (e.g., handheld, ona rolling cart, etc.). In some instances, all or a portion of thecomputing device 172 can be implemented as a bedside controller suchthat one or more processing steps described herein can be performed byprocessing component(s) of the bedside controller. An exemplary bedsidecontroller is described in U.S. Provisional Application No. 62/049,265,titled “Bedside Controller for Assessment of Vessels and AssociatedDevices, Systems, and Methods,” and filed Sep. 11, 2014, the entirety ofwhich is hereby incorporated by reference herein. Further, it isunderstood that in some instances the computing device 172 comprises aplurality of computing devices. In that regard, it is particularlyunderstood that the different processing and/or control aspects of thepresent disclosure may be implemented separately or within predefinedgroupings using a plurality of computing devices. Any divisions and/orcombinations of the processing and/or control aspects described belowacross multiple computing devices are within the scope of the presentdisclosure.

Together, connector 164, cable 166, connector 168, interface 170, andconnection 174 facilitate communication between the one or more sensors,transducers, and/or other monitoring elements of the instrument 152 andthe computing device 172. However, this communication pathway isexemplary in nature and should not be considered limiting in any way. Inthat regard, it is understood that any communication pathway between theinstrument 152 and the computing device 172 may be utilized, includingphysical connections (including electrical, optical, and/or fluidconnections), wireless connections, and/or combinations thereof. In thatregard, it is understood that the connection 174 is wireless in someinstances. In some instances, the connection 174 includes acommunication link over a network (e.g., intranet, internet,telecommunications network, and/or other network). In that regard, it isunderstood that the computing device 172 is positioned remote from anoperating area where the instrument 152 is being used in some instances.Having the connection 174 include a connection over a network canfacilitate communication between the instrument 152 and the remotecomputing device 172 regardless of whether the computing device is in anadjacent room, an adjacent building, or in a different state/country.Further, it is understood that the communication pathway between theinstrument 152 and the computing device 172 is a secure connection insome instances. Further still, it is understood that, in some instances,the data communicated over one or more portions of the communicationpathway between the instrument 152 and the computing device 172 isencrypted.

The system 150 also includes an instrument 175. In that regard, in someinstances instrument 175 is suitable for use as at least one ofinstruments 130 and 132 discussed above. Accordingly, in some instancesthe instrument 175 includes features similar to those discussed abovewith respect to instruments 130 and 132 in some instances. In theillustrated embodiment, the instrument 175 is a catheter-type device. Inthat regard, the instrument 175 includes one or more sensors,transducers, and/or other monitoring elements adjacent a distal portionof the instrument configured to obtain the diagnostic information aboutthe vessel. In the illustrated embodiment, the instrument 175 includes apressure sensor configured to monitor a pressure within a lumen in whichthe instrument 175 is positioned. The instrument 175 is in communicationwith an interface 176 via connection 177. In some instances, interface176 is a hemodynamic monitoring system or other control device, such asSiemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper IMPhysiomonitoring 5. In one particular embodiment, instrument 175 is apressure-sensing catheter that includes fluid column extending along itslength. In such an embodiment, interface 176 includes a hemostasis valvefluidly coupled to the fluid column of the catheter, a manifold fluidlycoupled to the hemostasis valve, and tubing extending between thecomponents as necessary to fluidly couple the components. In thatregard, the fluid column of the catheter is in fluid communication witha pressure sensor via the valve, manifold, and tubing. In someinstances, the pressure sensor is part of interface 176. In otherinstances, the pressure sensor is a separate component positionedbetween the instrument 175 and the interface 176. The interface 176 iscommunicatively coupled to the computing device 172 via a connection178.

The computing device 172 is communicatively coupled to a display device180 via a connection 182. In some embodiments, the display device 172 isa component of the computing device 172, while in other embodiments, thedisplay device 172 is distinct from the computing device 172. In someembodiments, the display device 172 is implemented as a bedsidecontroller having a touch-screen display as described, for example, inU.S. Provisional Application No. 62/049,265, titled “Bedside Controllerfor Assessment of Vessels and Associated Devices, Systems, and Methods,”and filed Sep. 11, 2014, the entirety of which is hereby incorporated byreference herein. The computing device 172 can generate screen displaysincluding data collected by the instruments 152 and 175 and otherinstruments, quantities computed based on the collected data,visualizations of the vessel in which the data is collected, andvisualizations based on the collected data and computed quantities.Exemplary screen displays are illustrated in FIGS. 7-28. The computingdevice 172 can provide the display data associated with the screendisplays to the display device 180.

The computing device 172 can additionally be communicatively coupled toa user interface device. The user interface device permits a user tointeract with the screen displays on the display device 180. Forexample, the user can provide a user input to modify all or a portion ofthe screen display using the user interface device. Exemplary userinputs and the corresponding modifications to the screen display areillustrated in FIGS. 7-28. In some embodiments, the user interfacedevice is a separate component from the display device 180. In otherembodiments, the user interface device is part of the display device180. For example, the user interface device can be implemented as abedside controller having a touch-screen display as described, forexample, in U.S. Provisional Application No. 62/049,265, titled “BedsideController for Assessment of Vessels and Associated Devices, Systems,and Methods,” and filed Sep. 11, 2014, the entirety of which is herebyincorporated by reference herein. In such embodiments, a user input canbe a touch input received on the touch sensitive display of the bedsidecontroller.

Similar to the connections between instrument 152 and the computingdevice 172, interface 176 and connections 177 and 178 facilitatecommunication between the one or more sensors, transducers, and/or othermonitoring elements of the instrument 175 and the computing device 172.However, this communication pathway is exemplary in nature and shouldnot be considered limiting in any way. In that regard, it is understoodthat any communication pathway between the instrument 175 and thecomputing device 172 may be utilized, including physical connections(including electrical, optical, and/or fluid connections), wirelessconnections, and/or combinations thereof. In that regard, it isunderstood that the connection 178 is wireless in some instances. Insome instances, the connection 178 includes a communication link over anetwork (e.g., intranet, internet, telecommunications network, and/orother network). In that regard, it is understood that the computingdevice 172 is positioned remote from an operating area where theinstrument 175 is being used in some instances. Having the connection178 include a connection over a network can facilitate communicationbetween the instrument 175 and the remote computing device 172regardless of whether the computing device is in an adjacent room, anadjacent building, or in a different state/country. Further, it isunderstood that the communication pathway between the instrument 175 andthe computing device 172 is a secure connection in some instances.Further still, it is understood that, in some instances, the datacommunicated over one or more portions of the communication pathwaybetween the instrument 175 and the computing device 172 is encrypted.

It is understood that one or more components of the system 150 are notincluded, are implemented in a different arrangement/order, and/or arereplaced with an alternative device/mechanism in other embodiments ofthe present disclosure. For example, in some instances, the system 150does not include interface 170 and/or interface 176. In such instances,the connector 168 (or other similar connector in communication withinstrument 152 or instrument 175) may plug into a port associated withcomputing device 172. Alternatively, the instruments 152, 175 maycommunicate wirelessly with the computing device 172. Generallyspeaking, the communication pathway between either or both of theinstruments 152, 175 and the computing device 172 may have nointermediate nodes (i.e., a direct connection), one intermediate nodebetween the instrument and the computing device, or a plurality ofintermediate nodes between the instrument and the computing device.

In some embodiments, the system 150 can additionally include a bedsidecontroller, such as the bedside controller described in U.S. ProvisionalApplication No. 62/049,265, titled “Bedside Controller for Assessment ofVessels and Associated Devices, Systems, and Methods,” and filed Sep.11, 2014, the entirety of which is hereby incorporated by referenceherein. The bedside controller may be utilized by a clinician to controlinstruments 152 and 175 to acquire pressure data during a procedure,watch real-time medical pressure measurements (e.g., visualrepresentations of pressure data, such as pressure waveforms, numericalvalues, etc.), compute pressure ratio(s) based on the collected pressuredata, and interact with the obtained medical sensing data, a visualrepresentation of the obtained medical sensing data and/or computedpressure ratio(s), a visualization based on the obtained medical sensingdata and/or computed pressure ratio(s), and/or a visual representationof the vessel 100. In that regard, the bedside controller can becommunicatively coupled to the computing device 172, the interfaces 170and 176, and/or the instruments 152 and 175.

In some embodiments, the system 150 can include an inventory database190 associated with a clinical environment, such as a hospital or otherhealthcare facility at which a PCI would be carried out on a patient.The inventory database can store various data about stents that areavailable to a clinician for use. The data can include manufacturernames, length, diameter, material, quantity available at the hospital,quantity available for immediate use, resupply frequency, next shipmentdate, and other suitable information. As described with respect to FIGS.27 and 28, the computing device 172 can compile a plurality of stentoptions based on the inventory database 190 and provide a selection menuto the clinician. The computing device 172 can provide automaticallyrecommend a particular stent (e.g., a stent from a particularmanufacturer, with a particular length, diameter, and/or material) basedon the PCI planning conducted using the graphical user interface. Thecomputing device 172 can also receive a user input selecting aparticular stent and provide it into the graphical user interface suchthat a clinician can assess the efficacy of treatment using the selectedstent. The computing device 172 is communicatively coupled to theinventory database 190 via a connection 192. The connection 192 can berepresentative of one or more network connections that communicativelycouple the computing device 172 with a computing system of thehealthcare facility.

Diagnostic information within a vasculature of interest can be obtainedusing one or more of instruments 130, 132, 152, and 175. For example,diagnostic information is obtained for one or more coronaries arteries,peripheral arteries, cerebrovascular vessels, etc. The diagnosticinformation can include pressure-related values, flow-related values,etc. Pressure-related values can include FFR (e.g., a pressure ratiovalue calculated as a first instrument is moved through a vesselrelative to a second instrument, including across at least one stenosisof the vessel), Pd/Pa (e.g., a ratio of the pressure distal to a lesionto the pressure proximal to the lesion), iFR (e.g., a pressure ratiovalue calculated using a diagnostic window relative to a distance as afirst instrument is moved through a vessel relative to a secondinstrument, including across at least one stenosis of the vessel), etc.Flow-related values can include coronary flow reserve or CFR (e.g.,maximum increase in blood flow through the coronary arteries above thenormal resting volume), basal stenosis resistance index (BSR), etc.

The diagnostic information and/or data obtained by instruments 130, 132,152, and/or 175 are correlated or co-registered to angiographic image(s)and/or other two-dimensional or three-dimensional depictions of apatient's vasculature obtained by an external imaging system. In variousembodiments, the diagnostic information obtained by the external imagingsystem can include externally-obtained angiographic images, x-rayimages, CT images, PET images, MRI images, SPECT images, and/or othertwo-dimensional or three-dimensional extraluminal depictions of apatient's vasculature. Spatial co-registration can be completed usingtechniques disclosed in U.S. Pat. No. 7,930,014, titled “VASCULAR IMAGECO-REGISTRATION,” which is hereby incorporated by reference in itsentirety, based on the known pullback speed/distance, based on a knownstarting point, based on a known ending point, and/or combinationsthereof. For example, a mechanical pullback device can be used toconduct the pressure-sensing procedure. The mechanical pullback devicecan move the pressure-sensing device through the vessel at a fixed,known rate. The location of the pressure measurements and/or thepressure ratio(s) can be determined based on the rate of the pullbackand a known location of the pressure-sensing device (e.g., a startposition, a mid-point position, an end position, available fromangiography data). In some embodiments, diagnostic information and/ordata is correlated to vessel images using techniques similar to thosedescribed in U.S. Provisional Patent Application No. 61/747,480, titled“SPATIAL CORRELATION OF INTRAVASCULAR IMAGES AND PHYSIOLOGICAL FEATURES”and filed Dec. 31, 2012, which is hereby incorporated by reference inits entirety. In some embodiments, co-registration and/or correlationcan be completed as described in U.S. Provisional Patent Application No.61/856,509, titled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OFVESSELS” and filed Jul. 19, 2013, which is hereby incorporated byreference in its entirety.

In some embodiments, diagnostic information and/or data is correlated tovessel images using techniques similar to those described in U.S. patentapplication Ser. No. 14/144,280, titled “DEVICES, SYSTEMS, AND METHODSFOR ASSESSMENT OF VESSELS” and filed Dec. 31, 2012, which is herebyincorporated by reference in its entirety. In some embodiments,co-registration and/or correlation can be completed as described in U.S.Provisional Patent Application No. 61/856,509, titled “DEVICES, SYSTEMS,AND METHODS FOR ASSESSMENT OF VESSELS” and filed Jul. 19, 2013, which ishereby incorporated by reference in its entirety. In other embodiments,co-registration and/or correlation can be completed as described inInternational Application No. PCT/IL2011/000612, titled “CO-USE OFENDOLUMINAL DATA AND EXTRALUMINAL IMAGING” and filed Jul. 28, 2011,which is hereby incorporated by reference in its entirety. Further, insome embodiments, co-registration and/or correlation can be completed asdescribed in International Application No. PCT/IL2009/001089, titled“IMAGE PROCESSING AND TOOL ACTUATION FOR MEDICAL PROCEDURES” and filedNov. 18, 2009, which is hereby incorporated by reference in itsentirety. Additionally, in other embodiments, co-registration and/orcorrelation can be completed as described in U.S. patent applicationSer. No. 12/075,244, titled “IMAGING FOR USE WITH MOVING ORGANS” andfiled Mar. 10, 2008, which is hereby incorporated by reference in itsentirety.

FIG. 5 is flowchart illustrating a method 500 of evaluating a vessel ofa patient. The method 500 will be described in the context of apressure-sensing procedure, such as an iFR, Pd/Pa, or FFR procedure. Itis understood that the method 500 can be carried out in the context of aflow-sensing procedure, such as a CFR procedure. The method 500 can bebetter understood with reference to FIGS. 7, 9, 11, 13, 15, 17, 19, 21,23, 25, and 27. At block 510, the method 500 includes obtaining pressuremeasurements. At block 520, the method 500 includes acquiringangiography data. In some embodiments, the pressure measurements areobtained simultaneously as the angiography data is acquired.Simultaneously collecting pressure measurements and angiography data canfacilitate co-registration, as described above. For example, thecollected pressure data can be co-registered such that the location ofthe pressure sensing component of the intravascular device within thevessel is known. A processing system can associate the location with thepressure measurements and/or the pressure ratio(s) at that location. Theprocessing system can also generate a screen display including thepressure measurements and/or pressure ratios at their associatedlocations, as described with respect to block 530.

A clinician can insert pressure-sensing intravascular device(s), such asa catheter or guidewire, into the patient. In some embodiments, theclinician may guide the intravascular device within the patient to adesired position using the angiography data. After the pressure sensingintravascular device has been appropriately positioned in the patient,the clinician can initiate collection of pressure measurements. Pressuremeasurements can be collected during one or more of the followingprocedures: an FFR “spot” measurement where the pressure sensor stays inone place while hyperemia is induced; an FFR pullback in which anelongated period of hyperemia is induced and the sensor is pulled backto the ostium; an iFR “spot” measurement that is similar to the FFR spotmeasurement but without hyperemia; and an iFR pullback which is that theFFR pullback but without hyperemia. In various embodiments,physiological measurement collection can be carried through acombination of one or more of the procedures described above.Physiological measurement can be continuous, such as during a pullbackprocedure. Physiological measurements can occur while the intravasculardevice is moved in one direction. Measurement collection can bediscontinuous procedure, such as when the intravascular device isselectively moved through the vessel (e.g., when movement of theintravascular device starts and stops, when the intravascular device isheld at various points along the vessel longer than others, etc.).Physiological measurements can occur while the intravascular device ismoved in both directions (e.g., proximally and distally within the bloodvessel). Co-registration can be used to ensure that, regardless of howthe physiological measurements were collected, the location of themeasurement can be identified on an angiographic image of the vessel.For example, a composite of the collected physiological measurements canbe generated based on the co-registered data.

In that regard, in some instances the pressure measurements arerepresentative of a pressure ratio between a fixed location within thevessel and the moving position of the instrument as the instrument ismoved through the vessel. For example, in some instances a proximalpressure measurement is obtained at a fixed location within the vesselwhile the instrument is pulled back through the vessel from a firstposition distal of the position where the proximal pressure measurementis obtained to a second position more proximal than the first position(i.e., closer to the fixed position of the proximal pressuremeasurement). For clarity in understanding the concepts of the presentdisclosure, this arrangement will be utilized to describe many of theembodiments of the present disclosure. However, it is understood thatthe concepts are equally applicable to other arrangements. For example,in some instances, the instrument is pushed through the vessel from afirst position distal of the proximal pressure measurement location to asecond position further distal (i.e., further away from the fixedposition of the proximal pressure measurement). In other instances, adistal pressure measurement is obtained at a fixed location within thevessel and the instrument is pulled back through the vessel from a firstposition proximal of the fixed location of the distal pressuremeasurement to a second position more proximal than the first position(i.e., further away from the fixed position of the distal pressuremeasurement). In still other instances, a distal pressure measurement isobtained at a fixed location within the vessel and the instrument ispushed through the vessel from a first position proximal of the fixedlocation of the distal pressure measurement to a second position lessproximal than the first position (i.e., closer the fixed position of thedistal pressure measurement).

In typical embodiments, a processing system can collect raw pressuredata from the intravascular device and process the data to computepressure differential(s) or ratio(s). The pressure differential betweenthe two pressure measurements within the vessel (e.g., a fixed locationpressure measurement and a moving pressure measurement) is calculated asa ratio of the two pressure measurements (e.g., the moving pressuremeasurement divided by the fixed location pressure measurement), in someinstances. In some instances, the pressure differential is calculatedfor each heartbeat cycle of the patient. In that regard, the calculatedpressure differential is the average pressure differential across aheartbeat cycle in some embodiments. For example, in some instanceswhere a hyperemic agent is applied to the patient, the average pressuredifferential across the heartbeat cycle is utilized to calculate thepressure differential. In other embodiments, only a portion of theheartbeat cycle is utilized to calculate the pressure differential. Thepressure differential is an average over the portion or diagnosticwindow of the heartbeat cycle, in some instances.

In some embodiments a diagnostic window is selected using one or more ofthe techniques described in U.S. patent application Ser. No. 13/460,296,filed Apr. 30, 2012 and titled “DEVICES, SYSTEMS, AND METHODS FORASSESSING A VESSEL,” which is hereby incorporated by reference in itsentirety. As discussed therein, the diagnostic windows and associatedtechniques are particularly suitable for use without application of ahyperemic agent to the patient. In general, the diagnostic window forevaluating differential pressure across a stenosis without the use of ahyperemic agent is identified based on characteristics and/or componentsof one or more of proximal pressure measurements, distal pressuremeasurements, proximal velocity measurements, distal velocitymeasurements, ECG waveforms, and/or other identifiable and/or measurableaspects of vessel performance. In that regard, various signal processingand/or computational techniques can be applied to the characteristicsand/or components of one or more of proximal pressure measurements,distal pressure measurements, proximal velocity measurements, distalvelocity measurements, ECG waveforms, and/or other identifiable and/ormeasurable aspects of vessel performance to identify a suitablediagnostic window.

Referring again to FIG. 5, at block 530, the method 500 includesdetermining PCI is the appropriate treatment for the vessel. Angiographydata, pressure measurements, and/or other data can be used to determinethat a vessel stenosis exists and that is it necessary to treat thevessel. Exemplary embodiments of determining to treat the vessel aredescribed in U.S. Provisional application Ser. No. ______ (AttorneyDocket No. 44755.1511), the entirety of which is hereby incorporated byreference herein.

The method 500 includes, at step 540, planning the PCI. Planning the PCIcan include interacting with a graphical user interface described hereinto determine physiologic parameters for the PCI, such as stent position,stent length, stent diameter, etc. Using the screen displays describedherein, a graphical representation of a stent positioned within a vesselcan be visualized. The screen displays can include various co-registeredphysiologic data, such as pressure ratio(s), overlaid on the vessel atthe location to which they are associated. The graphical representationof the stent can have various simulated or virtual properties, such asposition, length, diameter, etc., such that it appropriately fits withinthe visual representation of the vessel. For example, the properties ofthe graphical representation of the stent can be manually selected by aclinician, e.g., based on user input, and/or automatically determined bya computing device. The properties of the graphical representation ofthe stent can be varied in response to a user input. As described withrespect to block 580, real physiologic parameters for the PCI, such asstent position, stent length, stent diameter, etc., can be determinedbased on the simulated or virtual properties of the graphicalrepresentation of the stent. In this manner, angiographic data andphysiology measurements can be combined in a meaningful way to plan andevaluate the outcome of the PCI. The therapy plan and any modificationsto the stent parameters, as well as the predicted/anticipated outcome ofthe treatment, can be supported by collected data.

Planning the PCI (block 540) can include one or more of blocks 550, 560,and/570. At block 550, the method 500 includes outputting a screendisplay. The screen display includes a visualization based on thepressure measurements and a visual representation of the vessel. In someembodiments, the visual representation of the vessel is atwo-dimensional or three-dimensional angiographic image of the vessel,such as an angiographic image generated based on angiography datacollected at block 520. In some embodiments, visual representation ofthe vessel is two-dimensional or three-dimensional graphicalrepresentation of the vessel, such as a stylized image or reconstructionof the vessel. The visualization based on the pressure measurements caninclude numerical, graphical, textual, and/or other suitablevisualizations. For example, the visualization can include one or moreof a stent positioned within the visual representation of the vessel,calculated pressure ratio(s), markers indicative of a location withinthe vessel of the obtained pressure measurements or the calculatedpressure ratio(s), a label identifying the vessel, among others. Visualrepresentations of the vessel and visualizations based on the pressuremeasurements are described in the context of FIGS. 7-28. In someembodiments, the visualization based on the pressure measurements caninclude a heat map in which the visual representation of the vessel iscolorized or otherwise gradated to shows changes in the obtainedpressure measurements or calculated pressure ratio(s). Examples ofscreen displays including a heat map, calculated pressure ratios,markers indicative of a location associated with the obtained pressuremeasurements or the calculated pressure ratios, and other visualizationsare described in U.S. Provisional Application No. 61/895,909, titled“Devices, Systems, and Methods for Vessel Assessment,” and filed Oct.25, 2013, the entirety of which is hereby incorporated by referenceherein. In various embodiments, other collected data, computedquantities, etc., such as ECG waveforms, numerical values, can beprovided on the screen display as described in U.S. ProvisionalApplication No. 62/049,265, titled “Bedside Controller for Assessment ofVessels and Associated Devices, Systems, and Methods,” and filed Sep.11, 2014, the entirety of which is hereby incorporated by referenceherein. Other exemplary screen displays are described in the discussionof method 600 (FIG. 6).

At block 560, the method 500 includes receiving a user input to modifythe visualization. The user input can be to insert a stent into thevisual representation of the vessel and/or move the stent within thevessel. The user input can be to change one or more characteristics ofthe stent, such as length, diameter, material, etc. For example, theuser input can be to increase or decrease the length of the stent withinthe vessel. The user input can be received at a user interface device.In some embodiments, the user input is a touch input received at a touchsensitive display of a bedside controller. At block 570, the method 500includes modifying the visualization based on the user input. Forexample, in response to the user input, a stent can be inserted into thevisual representation of the vessel, the location of the stent withinthe vessel can be changed, and one or more characteristics of the stent(e.g., length, diameter, material, etc.) can be changed.

At block 580, the method 500 includes conducting the PCI using thephysiologic parameters identified during the PCI planning. Realphysiologic parameters (e.g., stent position, stent length, stentlength, etc.) can be determined based on the position, length, diameter,etc., of the graphical representation of the stent within the visualrepresentation of the vessel. For example, the computing device 172 cancorrelate the virtual/simulated characteristics of the graphicalrepresentation of the stent with the co-registered angiography data todetermine the real physiologic parameters of the stent. For example, thelength of the graphical representation of the stent can be correlated toan actual length within the vessel spanned by the stent using theangiographic image. In a similar manner, the position, diameter, andother virtual/simulated characteristics of the graphical representationof the stent can be correlated to corresponding, real physiologicparameters within the vessel using the angiographic image. In someembodiments, the dimensions of the vessel in the co-registeredangiography data can be determined using quantitative coronaryangiography (QCA), a known pullback speed, etc. The PCI can be carriedout on the patient to treat the occluded vessel using a stent with thedetermined real, physiologic parameters.

FIG. 6 is flowchart illustrating a method 600 of evaluating a vessel ofa patient. The method 600 is similar to the method 500, and the method600 will similarly be described in the context of a pressure-sensingprocedure, such as an iFR, Pd/Pa, or FFR procedure. It is understoodthat the method 600 can be carried out in the context of a flow-sensingprocedure, such as a CFR procedure. The method 600 can be betterunderstood with reference to FIGS. 7-28. Blocks 610, 620, and 630 aresimilar to blocks 510, 520, and 530 of method 500, described above.

The method 600 includes, at step 640, planning the PCI. Planning the PCIcan include interacting with a graphical user interface described hereinto determine physiologic parameters for the PCI, such as stent position,stent length, stent diameter, etc. Using the screen displays describedherein, a graphical representation of a stent positioned within a vesselor along a pressure curve can be visualized. The screen displays caninclude various co-registered physiologic data, such as pressureratio(s), overlaid on the vessel or pressure curve at the location towhich they are associated. The graphical representation of the stent canhave various simulated or virtual properties, such as position, length,diameter, etc., such that it appropriately fits within the visualrepresentation of the vessel. For example, the properties of thegraphical representation of the stent can be manually selected by aclinician, e.g., based on user input, and/or automatically determined bya computing device. The properties of the graphical representation ofthe stent, can be varied in response to a user input. As described withrespect to block 690, real physiologic parameters for the PCI, such asstent position, stent length, stent diameter, etc., can be determinedbased on the simulated or virtual properties of the graphicalrepresentation of the stent. In this manner, angiographic data andphysiology measurements can be combined in a meaningful way to plan andevaluate the outcome of the PCI. The therapy plan and any modificationsto the stent parameters, as well as the anticipated outcome of thetreatment, can be supported by the collected angiography and/or pressuredata.

Planning the PCI (block 640) can include one or more of blocks 650, 660,670, and/or 680. At block 650, the method 600 includes outputting ascreen display. The screen display includes a visual representation of apressure ratio and a visual representation of vessel. In someembodiments, the screen display can include both the visualrepresentation of the pressure ratio and the visual representation ofthe vessel, such as in a side by side configuration. In variousembodiments, other collected data, computed quantities, etc., such asECG waveforms, numerical values, can be provided on the screen displayas described in U.S. Provisional Application No. 62/049,265, titled“Bedside Controller for Assessment of Vessels and Associated Devices,Systems, and Methods,” and filed Sep. 11, 2014, the entirety of which ishereby incorporated by reference herein. Other exemplary screen displaysare described in the discussion of method 500 (FIG. 5). As similarlydescribed with respect to block 550, the visual representation of thevessel can include two-dimensional or three-dimensional angiographicimage or graphical representation of the vessel.

The visual representation of the pressure ratio can include a graph ofthe calculated pressure ratio over time or relative to alocation/position in the anatomy, such as the blood vessel. Exemplaryembodiments of the visual representations of the pressure ratio areillustrated in FIGS. 8a, 8b , 10, 12, 14, 16, 18, 20, 22, 24, 26, and28. The graph can show the pressure ratio calculated over the time ofobtaining pressure measurements or relative to a location/position inthe blood vessel, such as during a pullback. For example, the graph canshow an iFR or FFR pressure ratio value. In that regard, the iFRpressure ratio may be calculated as described in one or more of PCTPatent Application Publication No. WO 2012/093260, filed Jan. 6, 2012and titled “APPARATUS AND METHOD OF CHARACTERISING A NARROWING IN AFLUID FILLED TUBE,” PCT Patent Application Publication No. WO2012/093266, filed Jan. 6, 2012 and titled “APPARATUS AND METHOD OFASSESSING A NARROWING IN A FLUID FILLED TUBE,” U.S. patent applicationSer. No. 13/460,296, filed Apr. 30, 2012 and titled “DEVICES, SYSTEMS,AND METHODS FOR ASSESSING A VESSEL,” PCT Patent Application PublicationNo. WO 2013/028612, filed Aug. 20, 2012 and titled “DEVICES, SYSTEMS,AND METHODS FOR VISUALLY DEPICTING A VESSEL AND EVALUATING TREATMENTOPTIONS,” U.S. Provisional Patent Application No. 61/856,509, filed Jul.19, 2013 and titled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OFVESSELS,” and U.S. Provisional Patent Application No. 61/856,518, filedJul. 19, 2013 and titled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSING AVESSEL WITH AUTOMATED DRIFT CORRECTION,” each of which is herebyincorporated by reference in its entirety.

It is understood that the visual representation of the pressure ratiocan illustrate the pressure ratio and/or the underlying pressuremeasurements obtained by the multiple sensing components in any suitableway. Generally speaking, the representation of the data in the visualrepresentation of the pressure ratio can be utilized to identifygradients/changes in the pressure ratio and/or the underlying pressuremeasurements that can be indicative of a significant lesion in thevessel. In that regard, the visual representation of the data caninclude the pressure measurement(s); a ratio of the pressuremeasurements; a difference in the pressure measurements; a gradient ofthe pressure measurement(s), the ratio of the pressure measurements,and/or the difference in the pressure measurements; first or secondderivatives of the pressure measurement(s), the ratio of the pressuremeasurements, and/or the difference in the pressure measurements; and/orcombinations thereof.

At block 660, the method 600 includes receiving a user input to modifythe visual representation of the pressure ratio or visual representationof the vessel. The user input can be to insert a stent into the visualrepresentation of the vessel or the visual representation of thepressure ratio. The user input can be to move a stent within the vesselor along the visual representation of the pressure ratio. The user inputcan be to change one or more characteristics of the stent, such aslength, diameter, material, etc. For example, the user input can be toincrease or decrease the length of the stent within the vessel or alongthe visual representation of the pressure ratio. The user input can bereceived from a user interface device. In some embodiments, the userinput is a touch input received at a touch sensitive display of abedside controller. For example, a user input to modify the visualrepresentation of the pressure ratio can be received directly on a graphof the pressure ratio over time. For example, a user input to modify thevisual presentation of the vessel can be received directly on theangiographic image of the vessel.

At block 670, the method 600 includes modifying the selected one of thevisual representation of the pressure ratio and the visualrepresentation of the vessel. At block 680, the method 600 includescorrespondingly modifying the unselected one of the visualrepresentation of the pressure ratio and the visual representation ofthe vessel. For example, in response to a user input to modify thevisual representation of the vessel, a stent can be inserted into thevisual representation of the vessel. For example, the stent can be agraphical overlay positioned over an angiographic image of the vessel. Acorresponding stent can also be inserted in the visual representation ofthe pressure ratio. Similarly, in response to a user input to modify thevisual representation of the pressure ratio, a stent can be insertedalong the graph of the pressure ratio over time. A corresponding stentcan also be inserted into the visual representation of the vessel. Theuser directed modification and the automatic corresponding modificationcan be performed with various characteristics of a stent or othervisualization. For example, the screen display can be modified to changethe location of the stent along the visual representation of thepressure ratio, and the location of the stent within the vessel can becorrespondingly changed and vice versa. One or more characteristics ofthe stent (e.g., length, diameter, material, etc.) can be changed on thevisual representation of the pressure ratio, and the characteristic(s)can be correspondingly changed on the visual representation of thevessel and vice versa.

In some instances, one of the visual representation of the pressureratio and the visual representation of the vessel can be better suitedfor PCI planning. One or more methods described herein allow for aclinician to use the visual representation that is best suited for thecircumstances. For example, using the angiographic image may indicatethat a stent of a particular length is sufficient to remedy the changein pressure as a result of a lesion in the vessel. However, because thepressure sensing device takes a relatively directly route through thevessel, the angiographic image may underestimate the actual length ofthe stent that is required. In contrast, the visual representation ofthe pressure ratio may more accurately suggest a length of the stentrequired to address the pressure drop. Thus, a screen display of thevisual representation of the pressure ratio can be modified to include astent that has an increased length. The visual representation of thevessel can be correspondingly modified to include the longer stent. Inother embodiments, the visual representation of the vessel can provide amore accurate info for PCI planning and corresponding changes can bemade on the visual representation of the pressure ratio.

At block 690, the method 600 includes conducting the PCI using thephysiologic parameters identified during the PCI planning. Realphysiologic parameters (e.g., stent position, stent length, stentlength, etc.) can be determined based on the position, length, diameter,etc., of the graphical representation of the stent within the visualrepresentation of the vessel and/or along the pressure curve. Forexample, the computing device 172 can correlate the characteristics ofthe graphical representation of the stent with the co-registeredangiography data to determine the real physiologic parameters of thestent. For example, the length of the graphical representation of thestent can be correlated to an actual length within the vessel spanned bythe stent using the angiographic image or a known distance within thevessel between data points (e.g., pressure ratios) on the pressurecurve. In a similar manner, the position, diameter, and othervirtual/simulated characteristics of the graphical representation of thestent can be correlated to corresponding, real physiologic parameterswithin the vessel using the angiographic image or known dimensionswithin the vessel between data points (e.g., pressure ratios) on thepressure curve. In some embodiments, the dimensions of the vessel in theco-registered angiography can be determined using quantitative coronaryangiography (QCA), a known pullback speed, etc. The PCI can be carriedout on the patient to treat the occluded vessel using a stent with thedetermined real, physiologic parameters.

The discussion below generally refers to FIGS. 7-28. FIGS. 7-28 areexemplary screen displays (or partial screen displays) according toembodiments of the present disclosure. FIGS. 7, 9, 11, 13, 15, 17, 19,21, 23, 25, and 27 illustrate screen displays including a visualrepresentation of a vessel. FIGS. 8a, 8b , 10, 12, 14, 16, 18, 20, 22,24, 26, and 28 illustrate screen displays including a visualrepresentation of the pressure ratio. FIGS. 7-28 can be displayed on adisplay device of system assessing a patient's vasculature, such as thedisplay device 180 associated with computing device 172 (FIG. 4). Thatis, one or more components (e.g., a processor and/or processing circuit)of the system (e.g., computing device 172) can provide display data tocause the images of FIGS. 7-28 to be shown on a display device (e.g.,display device 180). The pressure ratio values illustrated in FIGS. 7-28are exemplary.

FIG. 7 illustrates a screen display 700 (or partial screen display)including a visual representation of a vessel. The data depicted in thescreen display 700 (FIG. 7) corresponds to the data shown in screendisplays 800 and 850 (FIGS. 8a and 8b ). The screen display includes avisual representation of a vessel 702 into which an intravascular devicehaving a pressure sensing component is guided. Angiographic and pressuredata can be collected with the intravascular device within the vessel702. For example, the pressure data can be collected during a pullbackprocedure, which in the embodiment of FIG. 7 is from the right to theleft of the vessel 702. The collected angiography data can be used togenerate an angiographic image including the vessel 702 and other branchvessels 704. The one or more visualizations described herein can be agraphical overlay on the angiographic image. The screen display 700includes label fields 706 identifying the particular vessel(s). In someembodiments, a computing device (e.g., computing device 172 of FIG. 4)uses the angiography data, such as the contours, location, branches, andother features of the vessel(s) to automatically identify the vessel.The position and/or viewing angle of the external imaging system (e.g.,angiography or x-ray system) can also be used to identify the vessel. Acomputing device can generate the display data associated with thelabels 706, including alphabetical, numerical, alphanumeric, and/orsymbolic characters. In the embodiment of FIG. 7, the labels 706 includean abbreviation of the identified vessel, such as “RCA” for rightcoronary artery and “PLA” for postero-lateral artery. Whileabbreviations and particular vessels are used in FIG. 7, it isunderstood that any suitable label can be used. In some embodiments, auser can selectively activate or deactivate one or more of the labels706 such that a portion, all, or none of the labels 706 are included inthe screen display 700.

The screen display 700 also includes markers 708 indicative of alocation within the vessel 700 associated with the collected pressuremeasurements or computed pressure ratio. For example, the markers 708can be a location of the pressure sensor when the pressure measurementsare collected. In the embodiment of FIG. 7, the markers 708 are linesegments that transect the vessel 702. Other examples of markersindicative of location are described in U.S. Provisional Application No.61/895,909, titled “Devices, Systems, and Methods for VesselAssessment,” and filed Oct. 25, 2013, the entirety of which is herebyincorporated by reference herein. In one embodiment, such as during aniFR procedure, one pressure ratio is computed per heartbeat cycle. Thus,each marker 708 is indicative of collected data and/or computed pressureratio during the heartbeat cycle. In some embodiments, a user canselectively activate or deactivate one or more of the markers 708 suchthat a portion, all, or none of the markers 708 are included in thescreen display 700. The markers 708 can be separated by varyingdistances within the vessel 702, as indicated by distances 710 and 712.In turn, the distances 710 and 712 can correspond to the speed throughwhich the pressure sensing device is guided through the vessel 702. Inembodiments in which the pressure sensing device is guided through thevessel 702 at a constant speed, the distance between the markers 708 isequal or nearly equal such that successive markers 702 are positioned atequal or nearly equal intervals. In the embodiments in which thepressure sensing device is guided through the vessel 702 at anon-constant speed, the distance between the markers 708 will vary to agreater extent such that successive markers 708 are positioned atunequal intervals. For example, the pressure sensing device can beslowed down near an obstruction such that data from a relatively greaternumber of heartbeat cycles is collected. As illustrated in FIG. 7, thereis less distance between successive markers 708 around a pressure changeattributable to an obstruction in the vessel 702. Co-registration can beimplemented such that the location of the pressure sensing intravasculardevice within the vessel 702 is known during each heartbeat cycle. As aresult, the pressure sensing intravascular device can be guided throughthe vessel 702 (e.g., during a pullback procedure) with a non-constantspeed such that the pace of data collection in the vessel 702 can becontrolled by the clinician. For example, the clinician can slow downfor more information near a clinically significant portion of the vessel702 such as a lesion. For example, the clinician can speed up throughnon-clinically significant portions of the vessel 702.

The pressure change in the vessel 702 is indicated by the pressure ratiofields 714. The pressure ratio fields are provided adjacent the markers708. In the embodiment of FIG. 7, only a portion of the pressure ratiofields 714 are shown. In various embodiments, a portion, all, or none ofthe pressure ratio fields 714 can provide the computed pressure ratioassociated with a given location. For example, a user can selectivelyactivate or deactivate one or more of the pressure ratio fields 714. Invarious embodiments, the pressure ratio fields 714 include alphabetical,numerical, alphanumeric, and/or symbolic characters. In FIG. 7, thefields 714 include are numeric values associated with an iFRcalculation. In other embodiments, the fields 714 can include an “FFR,”“iFR,” “Pd/Pa,” or other label to identify the type of quantity beingdisplayed. Such embodiments are described, for example, in U.S.Provisional Application No. 61/895,909, titled “Devices, Systems, andMethods for Vessel Assessment,” and filed Oct. 25, 2013, the entirety ofwhich is hereby incorporated by reference herein. A pressure change isindicated by the values in the fields 714. For example, in FIG. 7, anobstruction in the vessel 702 likely exists between the values 0.93 and0.81.

The screen display 700 additionally includes an insert stent field 716.Selection of the insert stent field 716 can be a user input to modifythe visual representation of the vessel and/or a visualization based onthe pressure measurements. In some embodiments, selection of the insertstent field 716 can cause a computing device (e.g., computing device172) to determine one or more recommended characteristics of a stent tobe deployed within the vessel 702, including position, diameter, length,material, etc. The determination of the one or more characteristics canbe based on the collected pressure data, computed pressure ratio(s),angiography data, a threshold pressure ratio, a target pressure ratio,an ideal pressure ratio, etc. In that regard, the stent can be describedas a visualization based on pressure measurements. For example, thecharacteristics, such as the position and length, of the stent can beselected to remedy a drop in the pressure ratio across an obstruction.The computing device can determine the characteristics of the stent andgenerate display data to cause a stent to be displayed within the vessel702 (as illustrated in FIG. 9). As described below, a clinician canmodify the recommended characteristics of the stent. In someembodiments, selection of the insert stent field 716 provides a stentwithout determining its characteristics based on the collected pressuredata, computed pressure ratio(s), and/or angiography data. In thismanner, a clinician can customize the characteristics of the stent. Forexample, a clinician can provide a user input (such as a click and drag,or other suitable input) along the vessel 702, and computing device canprovide a graphical representation of a stent having the lengthcorresponding to the distance traversed by the user input along thevessel 702. In some embodiments, a plurality of stent options can beprovided when the insert stent field 716 is selected, as described ingreater detail with respect to FIG. 25.

FIGS. 8a and 8b illustrate screen displays 800 and 850 (or partialscreen displays) including a visual representation of a pressure ratio.The data depicted in the screen displays 800 and 850 (FIGS. 8a and 8b )corresponds to the data shown in screen display 700 (FIG. 7). The screendisplays 800 and 850 include curves 802, 852 respectively of thepressure ratios within the vessel 702. The curves 802, 852 arerepresentative of the same data, except that the x-axes are different.The screen display 800 (FIG. 8a ) includes time or distance on thex-axis and a pressure ratio quantity (such as iFR, FFR, Pd/Pa, etc.) onthe y-axis. For example, in the embodiment shown in FIG. 7, a movingpressure sensing device can be guided from right to left within thevessel 702 during the pullback procedure while a fixed pressure sensingdevice remains stationary on the left side of the vessel 702. Valuesalong the x-axis of screen display 800 can correspond to the duration ofa pullback procedure and/or distance traveled by the moving pressuresensing device during the pullback procedure. The screen display 850includes position corresponding to the physical orientation of thevessel 702 along the x-axis and a pressure ratio quantity (such as iFR,FFR, Pd/Pa, etc.) on the y-axis. That is, the screen display 850 showsthe pressure ratios associated with the left side of the vessel 702 onthe left side of the curve 852 and the pressure ratios associated withthe right side of the vessel 702 on the right side of the curve 852. Insome instances, providing a pressure ratio plot that corresponds to thephysical location along the vessel can facilitate easier PCI planning.The discussion below generally refers to the screen display 850, but itis understood that the screen display 800 can be equivalently utilized.

The screen displays 800 and 850 include an ideal pressure ratio line806. The ideal line 806 is representative of a pressure ratio equal toone (1), which is indicative of a vessel with no obstructions.Physiologically, a pressure ratio equal to one (1) is the maximumpossible pressure ratio and occurs when proximal and distal pressuremeasurements are equal. During PCI planning, a clinician tries todetermine stent parameters that will cause a patient's pressure ratiosto return as closely as possible to the ideal line 806.

The screen displays 800 and 850 include a threshold pressure ratio 804.The threshold 804 can be set at a value indicative of transition betweenpressure ratios representative of a healthy vessel and pressure ratiosrepresentative of a vessel having an obstruction. Pressure ratios abovethe threshold 804 can be representative of a vessel for which treatmentis not recommended, and pressure ratios below the threshold 804 can berepresentative of a vessel for which treatment is recommended. Thethreshold 804 can vary depending on the pressure ratio scale (e.g., iFR,FFR, Pd/Pa, etc.) used in the screen displays 800 and 850. For example,the threshold 804 for FFR can be 0.80, and the threshold 804 for iFR canbe 0.89. For example, if a vessel has FFR values above 0.80, theclinician can determine not to treat the vessel. If the vessel has FFRvalues below 0.80, the clinician can determine to treat the vessel witha PCI.

The screen displays 800 and 850 include a target line 820. The targetline 820 can correspond to a pressure ratio value that is associatedwith clinically beneficial outcomes for the patient. The target line 820can correspond to a pressure ratio value higher than the threshold 804in some embodiments. That is, the threshold 804 can represent a minimumpressure ratio value that can be considered healthy, while the targetline 820 can represent a higher pressure ratio value that is associatedwith efficacious treatment. The target line 820 can vary depending onthe pressure ratio scale (e.g., iFR, FFR, Pd/Pa, etc.) used in thescreen displays 800 and 850. For example, the target line 820 for FFRcan be 0.93. The graphical user interface for PCI planning can allow theclinician to set the pressure ratio value for the threshold 804 and/orthe target line 820. For example, the clinician can access settingsoptions that allow for modification of the threshold 804 and/or thetarget line 820. One of the goals during insertion of a stent during aPCI is to return, as closely as possible, the actual pressure ratiovalues of the curves 802 and 852 to the value indicated by the idealline 806. However, it may not be medically possible to recreate perfectflow within the stenosed vessel. In such circumstances, the target line820 represents a medically acceptable pressure ratio values that areindicative of efficacious treatment. Thus, during PCI planning, theclinician determines stent parameters to return the patient's pressureratio values to as close to the ideal line 806 as possible and at leastabove the target line 820. The threshold 804, the target line 820,and/or the ideal line 806 can be selectively provided on the screendisplays 800 and 850, in response to a user input to show/hide thevisualizations. While the threshold 804 and the target line 820 areshown in FIGS. 10, 12, 14, 16, 18, 20, 22, 24, 26, and 28, it isunderstood that none or any one or more the threshold 804, the targetline 820, and/or the ideal line 806 can be provided on the screendisplays.

In some embodiments, various colors and/or other visual indicators areprovided on the screen displays 800 and 850 to indicate a differencebetween the threshold 804 and the actual pressure ratio. For example, afirst color (e.g., green, white, or otherwise) can be utilized torepresent values well above the threshold value (e.g., where thethreshold value is 0.80 on a scale of 0.00 to 1.00, values above 0.90),a second color (e.g., yellow, gray, or otherwise) can be utilized torepresent values near but above the threshold value (e.g., where thethreshold value is 0.80 on a scale of 0.00 to 1.00, values between 0.81and 0.90), and a third color (e.g., red, black, or otherwise) can beutilized to represent values equal to or below the threshold value(e.g., where the threshold value is 0.80 on a scale of 0.00 to 1.00,values of 0.80 and below). It is appreciated that any number of colorcombinations, scalings, categories, and/or other characteristics can beutilized to visually represent the relative value of the pressuredifferential to the threshold value. However, for the sake of brevityApplicants will not explicitly describe the numerous variations herein.

The screen displays 800 and 850 additionally include markers 808 andpressure ratio fields 814. The markers 808 and pressure ratio fields 814are similar to those described in the context of FIG. 7. While thecurves 802 and 852 are depicted as continuous in FIGS. 8a and 8b , themarkers 808 can be representative of actual data points on the curves802 and 852. The values of the curves 802 and 852 between the markers808 can be interpolated based on the pressure ratios associated with themarkers 808. A computing device (e.g., computing device 172 of FIG. 4)can provide data processing, data interpolation, smoothing, and performother computations to generate the pressure ratio curves 802 and 852.The ideal pressure ratio line 806, the threshold 804, markers 808, andpressure ratio fields 814 can be selectively activated and deactivatedsuch that a portion, all, or none appear the screen displays 800 and850.

The screen displays 800 and 850 additionally include an insert stentfield 816. Selection of the insert stent field 816 can be a user inputto modify the visual representation of the pressure ratio. As similarlydescribed with respect to FIG. 7, in some embodiments, selection of theinsert stent field 816 can cause a computing device (e.g., computingdevice 172 of FIG. 4) to determine one or more recommendedcharacteristics of a stent to be deployed along the curves 802 or 852,including the stent position, diameter, length, material, etc. Thedetermination of the one or more characteristics can be based on thecollected pressure data, computed pressure ratio(s), angiography data, athreshold pressure ratio, a target pressure ratio, an ideal pressureratio, etc. In that regard, the stent can be described as avisualization based on pressure measurements. For example, thecharacteristics, such as the position and length, of the stent can beselected to span a drop in the pressure ratio curve. The computingdevice can determine the characteristics of the stent and generatedisplay data to cause a stent to be displayed along the curves 802 and852 (as illustrated in, e.g., FIG. 10). As described below, a cliniciancan modify the recommended characteristics of the stent. In someembodiments, selection of the insert stent field 816 provides a stentwithout determining its characteristics based on the collected pressuredata, computed pressure ratio(s), and/or angiography data. In thismanner, a clinician can customize the characteristics of the stent. Forexample, a clinician can provide a user input (such as a click and drag,or other suitable input) along the curves 802 and/or 852, and computingdevice can provide a graphical representation of a stent having thelength corresponding to the distance traversed by the user input alongthe curves 802 and/or 852. In some embodiments, a plurality of stentoptions can be provided when the insert stent field 816 is selected, asdescribed in greater detail with respect to FIG. 26.

FIG. 9 illustrates a screen display 900 (or partial screen display)including a visual representation of a vessel. The data depicted in thescreen display 900 (FIG. 9) corresponds to the data shown in screendisplay 1000 (FIG. 10). A graphical representation of a stent 902 ispositioned in the visual representation of the vessel 702. The stent 902can be inserted into the vessel in response to a user input to modifythe visual representation of the vessel and/or modify a visualizationbased on the pressure measurements. As described above, the location,length, diameter, material, and/or other characteristics can beautomatically generated by a computing device and corresponding displaydata can be provided to a display device. For example, the diameter ofthe stent can be auto-sized to match the diameter of the vessel in theangiographic image. The image characteristics of the stent 902 thatdetermine how the stent 902 appears in the screen display 900 can bechosen such that the stent 902 is visually distinguishable within thevessel 702. The image characteristics can include a color, shading,pattern, transparency, borders, and other related characteristics. Insome embodiments, the image characteristics of the stent 902 areselected to match the physical appearance of an actual stent. In someembodiments, the image characteristics of the stent 902 are selected tohighlight a region within the vessel 702 in which the stent is inserted.Real physiologic values for a stent to be positioned within an occludedvessel of a human patient can be determined based on the location,length, diameter, material, and/or other virtual/simulatedcharacteristics of the graphical representation of the stent 902.

FIG. 10 illustrates a screen display 1000 (or partial screen display)including a visual representation of a pressure ratio. The data depictedin the screen display 1000 (FIG. 10) corresponds to the data shown inscreen display 900 (FIG. 9). A graphical representation of a stent 1002is positioned along the visual representation of the pressure ratiocurve 852. The characteristics of the graphical representation of stent1002, such as the position and length, among others, correspond to thecharacteristics of the graphical representation of stent 902 that ispositioned within the vessel 702 (FIG. 9). The stent 1002 can beinserted along the pressure ratio curve 852 in response to a user inputto modify the visual representation of the pressure ratio and/or modifya visualization based on the pressure measurements. As described above,the location, length, diameter, material, and/or other physicalcharacteristics can be automatically generated by a computing device andcorresponding display data can be provided to a display device. Theimage characteristics of the stent 1002 that determine how the stent1002 appears in the screen display 100 can be chosen such that the stent1002 is visually distinguishable along the curve 852. The imagecharacteristics can include a color, shading, pattern, transparency,borders, and other related characteristics. In some embodiments, theimage characteristics of the stent 1002 are selected to match thephysical appearance of an actual stent. In some embodiments, the imagecharacteristics of the stent 1002 are selected to highlight a regionalong the curve 852 where the stent is inserted. Real physiologic valuesfor a stent to be positioned within an occluded vessel of a humanpatient can be determined based on the location, length, diameter,material, and/or other virtual/simulated characteristics of thegraphical representation of the stent 1002.

The screen display 1000 includes corrected pressure curve 1004. Thecorrected pressure curve 1004 represents the anticipated changes topressure curve 852 as a result of the deployment of the stent 1002, atthe current location and with the current characteristics, such aslength. No change in the pressure is expected across the length of thestent 1002, as illustrated in the corrected pressure curve 1004. Thatis, placement of the stent 1002 is ideally creating perfect or nearperfect flow across that portion of the vessel 702. An end of the stent1002 can be indicated by a stent end notation 1006. In differentembodiments, various other graphical representations of the stent endcan be utilized. The stent end notation 1006 can be selectively providedto the screen display 1000, e.g., based on a user input to show/hide thevisualization. The stent end notation 1006 is representative of thepoint beyond which the corrected pressure curve 1004 is expected tobehave like the pressure curve 852. As shown, the corrected pressurecurve 1004 is shaped similar to the pressure curve 852, past the stentend notation 1006. However, the pressure values indicated by thecorrected pressure curve 1004 are higher as a result of the stent 1002correcting at least a portion of the pressure drop across a lesion inthe vessel.

Screen display 1000 additionally includes a corrected pressure ratiovalue 1010. The corrected pressure ratio value 1010 can correspond tothe numerical value of the corrected pressure ratio curve 1004. One orboth of the corrected pressure ratio value 1010 and the correctedpressure ratio curve 1004 can provide a clinician validation that theselected treatment will achieve the clinical goal of reducing pressureloss in the vessel. For example, the threshold 804 can correspond to aniFR value of 0.89, above which vessels can be characterized as healthy.If the corrected pressure ratio value 1010 provides an iFR value that isgreater than 0.89 (as it does in the embodiment of FIG. 10), theclinician can understand that the placement of the stent with the givenparameters (e.g., length, diameter, position, etc.) will provide somebenefit in treating the vessel. The clinician can also understand thatthe proposed stent parameters do not result in the corrected pressureratio curve 1004 or the corrected pressure ratio value 1004 equaling orexceeding the target line 820, at which clinical benefits are likely toresult from the therapeutic intervention. Thus, the clinician can varythe stent parameters, as described herein, to move the stent, modify thestent length, etc., to plan a PCI that results in a corrected pressureratio that exceeds the target line 820. In some embodiments, a cliniciancan make a medical determination that it is infeasible for the correctedpressure ratio curve 1004 to reach the target line 820 and thattreatment to raise the corrected pressure ratio curve 1004 above thethreshold 804 is sufficient. The corrected pressure ratio value 1010 canbe associated with the distal portion of the corrected pressure ratiocurve 1004 (e.g., the distal most value, an average of values of thecorrected pressure ratio curve, etc.). The corrected pressure ratiovalue 1010 can be provided adjacent corrected pressure ratio curve 1004.The corrected pressure ratio value 1010 can be selectively provided inresponse to a user input to show/hide the visualization.

A computing device (e.g., computing device 172) can compute the valuesof the corrected pressure curve 1004 based on the obtained pressuremeasurements, calculated pressure ratios, target pressure ratio, idealpressure ratio, etc. The corrected pressure curve 1004 can be computedand provided in real time such that the curve 1004 is adjusted based onmodifications to the location and length of the stent 1002, among otherphysical characteristics, made by a clinician. The clinician can modifythe physical characteristics of the stent so that the values of thecorrected pressure curve are as close to being equal to an idealpressure ratio (such the ideal pressure ratio line 806 of FIG. 8b )and/or at least greater than a target pressure ratio (such as the targetline 820 of FIG. 8b ).

In some embodiments, inserting a graphical representation of a stent inthe vessel 702 of the screen display 900 (FIG. 9) can cause a graphicalrepresentation of a stent to be correspondingly inserted along thepressure ratio curve 852 of the screen display 1000 (FIG. 10).Similarly, inserting a stent along the pressure ratio curve 852 of thescreen display 1000 (FIG. 10) can cause the stent to be correspondinglyinserted in the vessel 702 of the screen display 900. In this manner, aclinician can conduct PCI planning while interacting directly with aselected one of the screen displays 900 and 1000, while automaticallyviewing corresponding changes in the unselected one of the screendisplays 900 and 1000.

FIGS. 11-14 describe movement of a stent within the vessel and along apressure ratio curve. FIG. 11 illustrates a screen display 1100 (orpartial screen display) including a visual representation of a vessel.The data depicted in the screen display 1100 (FIG. 11) corresponds tothe data shown in screen display 1200 (FIG. 12). The graphicalrepresentation of the stent 902 can be moved within the vessel 702. Thatis, the position of the stent 902 with the vessel 702 can be changed inresponse to a user input to move the stent 902. The user input to movethe stent 902 can be described as a user input to modify a visualizationbased on the pressure ratio or a visual representation of the vessel. Insome embodiments, a stent options menu 1104 can provide options 1106 and1108 to move the stent 902 to the left or to the right within the vessel702. In some embodiments, such as when the screen display 1100 isprovided on a touch-sensitive display, a user can use one or more touchinputs on the stent 902 itself to move the stent within the vessel 702.For example, a user can touch and drag the stent 902 to a differentposition. In the embodiment of FIG. 11, the screen display 1100 is shownto be in an intermediate stage in which the stent 902 is being moved tothe left to a new position 1102 in response to a corresponding userinput. Screen display 1300 of FIG. 13 shows the stent 1302 at the newposition in the vessel 702. The data depicted in the screen display 1300(FIG. 13) corresponds to the data shown in screen display 1400 (FIG.14).

FIG. 12 illustrates a screen display 1200 (or partial screen display)including a visual representation of a pressure ratio. The data depictedin the screen display 1200 (FIG. 12) corresponds to the data shown inscreen display 1100 (FIG. 11). The graphical representation of the stent1002 can be moved along the pressure ratio curve 852. That is, theposition of the stent 1002 along the curve 852 can be changed inresponse to a user input to move the stent 1002. The user input to movethe stent 1002 can be described as a user input to modify avisualization based on the pressure ratio or a visual representation ofthe pressure ratio. In some embodiments, a stent options menu 1204 canprovide options 1206 and 1208 to move the stent 1002 to the left or tothe right along the curve 852. In some embodiments, such as when thescreen display 1200 is provided on a touch-sensitive display, a user canuse one or more touch inputs on the stent 1002 itself to move the stentalong the curve 852. For example, a user can touch and drag the stent1002 to a different position. In the embodiment of FIG. 12, the screendisplay 1200 is shown to be in an intermediate stage in which the stent1002 is being moved to the left to a new position 1202 in response to acorresponding user input. In some embodiments, the corrected pressureratio curve 1004 can be updated in real time such that, as the stent1002 is being moved, the curve 1004 is adjusted to reflect the predictedpressure ratio with the stent 1002 in the contemporaneous position.Screen display 1400 of FIG. 14 shows the stent 1402 at the new positionalong the curve 852. The data depicted in the screen display 1400 (FIG.140) corresponds to the data shown in screen display 1300 (FIG. 13).Screen display 1400 also provides a corrected pressure ratio curve 1004that is updated based on the new position of the stent 1402. Forexample, the curve 1004 of FIG. 14 is above the target line 820, whichis indicative of that fact that the stent 1402 is better positioned(compared to the original position of the stent 1002 in FIG. 12)relative to an obstruction in the vessel 702 to remedy the changes inpressure caused by the obstruction. A corrected pressure ratio curve1004 at least above the target line 820 can be a goal of the clinicianduring PCI planning. In response to the selected virtual/simulatedcharacteristics of the stent 1402, the computing device predicts thatthe goal will be reached based on the collected pressure data. Thevirtual/simulated characteristics of the stent 1402 can be correlated toreal, physiological parameters of a stent to be positioned within thehuman vessel to treat a patient based on the PCI planning. Thus,movement of the graphical representation of the stent allows a clinicianto choose an appropriate physiologic location for stent deployment tomaximize clinical efficacy during PCI planning.

In some embodiments, moving the stent in the vessel 702 of the screendisplay 1100 (FIG. 11) can cause the stent to be correspondingly movedalong the pressure ratio curve 852 of the screen display 1200 (FIG. 12).Similarly, moving a stent along the pressure ratio curve 852 of thescreen display 1200 (FIG. 12) can cause the stent to be correspondinglymoved in the vessel 702 of the screen display 1100 (FIG. 11). In thismanner, a clinician can conduct PCI planning while interacting directlywith a selected one of the screen displays 1100 and 1200, whileautomatically viewing corresponding changes in the unselected one of thescreen displays 1100 and 1200. For example, a clinician can workdirectly on the screen display 1200 that illustrates the pressure ratiocurve 852 and the positioning of the stent relative to the pressureratio curve. The stent can be moved along the pressure ratio curve 852such that the corrected pressure ratio curve 1004 more closely matchesor exceeds the target line 820. A corresponding change in the positionof the stent can be made on the screen display 1100 (FIG. 11) of thevessel such that a clinician understands where the stent should bedeployed in the vessel to achieve the corrected pressure ratio curve.

FIGS. 15-24 describe changing the length of a stent within the vesseland along a pressure ratio curve. In particular, FIGS. 17-20 describeshortening a stent, and FIGS. 21-24 describe lengthening a stent. FIG.15 illustrates a screen display 1500 (or partial screen display)including a visual representation of a vessel. The data depicted in thescreen display 1500 (FIG. 15) corresponds to the data shown in screendisplay 1600 (FIG. 16). The length of the graphical representation ofthe stent 1502 can be decreased or increased within the vessel 702. Thatis, the stent 1502 within the vessel 702 can be shortened or lengthenedin response to a user input to shorten or to lengthen the stent 1502,respectively. The user input to shorten or lengthen the stent 1502 canbe described as a user input to modify a visualization based on thepressure ratio or a visual representation of the vessel. In someembodiments, a stent options menu 1504 can provide options 1506 and 1508to increase or decrease, respectively, the length of the stent 1502. Insome embodiments, such as when the screen display 1500 is provided on atouch-sensitive display, a user can use one or more touch inputs on thestent 1502 itself to change the length of the stent within the vessel702. For example, a user can touch and drag one, the other, or both ofthe ends of the stent 1502 (as described in greater detail with respectto FIGS. 17 and 21). FIG. 15 illustrates the stent 1502 before a userinput to change the length of the stent is received.

FIG. 16 illustrates a screen display 1600 (or partial screen display)including a visual representation of a pressure ratio. The data depictedin the screen display 1600 (FIG. 16) corresponds to the data shown inscreen display 1500 (FIG. 15). The length of the stent 1602 can beincreased or decreased along the pressure ratio curve 852. That is, thestent 1602 along the curve 852 can be shortened or lengthened inresponse to a user input to shorten or lengthen the stent 1602,respectively. The user input to shorten of lengthen the stent 1602 canbe described as a user input to modify a visualization based on thepressure ratio or a visual representation of the pressure ratio. In someembodiments, a stent options menu 1604 can provide options 1606 and 1608to increase or decrease, respectively, the length of the stent 1602. Insome embodiments, such as when the screen display 1600 is provided on atouch-sensitive display, a user can use one or more touch inputs on thestent 1602 itself to change the length of the stent along the curve 852.For example, a user can touch and drag one, the other, or both of theends of the stent 1602 (as described in greater detail with respect toFIGS. 18 and 22). FIG. 16 illustrates the stent 1602 before a user inputto change the length of the stent is received.

FIG. 17 illustrates a screen display 1700 (or partial screen display)including a visual representation of a vessel. The data depicted in thescreen display 1700 (FIG. 17) corresponds to the data shown in screendisplay 1800 (FIG. 18). In the embodiment of FIG. 17, the screen display1700 is shown to be in an intermediate stage in which the length ofstent 1702 is being decreased in response to a corresponding user input.In some embodiments, the user input is the selection of the shortenoption 1508. Selection of the shorten option 1508 can cause the lengthof the stent 1702 to be decreased by a fixed or variable amount on one,the other, or both of the ends 1706. In some embodiments, such as whenthe user input is received on a touch sensitive display, the user inputcan include a touch on one, the other, or both of the ends 1706 and adrag towards the center of the stent 1702. In the embodiment of FIG. 17,as a result of the user input, the stent 1702 can be shortened by thelengths 1704 on both ends of the stent. While the lengths 1704 on bothends 1706 of the stent 1702 are approximately equal in FIG. 17, it isunderstood that the stent can be shortened by different lengths on theends 1706. It is also understood that that the stent 1702 can beshortened on only one end 1706. Screen display 1900 of FIG. 19 shows thestent 1902 with the modified, shorter length in the vessel 702. The datadepicted in the screen display 1900 (FIG. 19) corresponds to the datashown in screen display 2000 (FIG. 20).

FIG. 18 illustrates a screen display 1800 (or partial screen display)including a visual representation of a pressure ratio. The data depictedin the screen display 1800 (FIG. 18) corresponds to the data shown inscreen display 1700 (FIG. 17). In the embodiment of FIG. 18, the screendisplay 1800 is shown to be in an intermediate stage in which the lengthof stent 1802 is being shortened in response to a corresponding userinput. In some embodiments, the user input is the selection of theshorten option 1608. Selection of the shorten option 1608 can cause thelength of the stent 1802 to be shortened by a fixed amount on one, theother, or both of the ends 1806. In some embodiments, such as when theuser input is received on a touch sensitive display, the user input caninclude a touch on one, the other, or both of the ends 1806 and a dragtowards the center of the stent 1802. In the embodiment of FIG. 18, as aresult of the user input, the stent 1802 can be shortened by the lengths1804 on both ends of the stent. In some embodiments, shortening thelength of the stent 1802 on the side adjacent the pressure curve 852 cancause the stent 1802 to move from the original position of the stent1602. That is, shortening the length on the left side of the stent 1602(in the embodiment of the FIG. 18) results both in the length of thestent changing as well as the position of the stent moving to the right.In some embodiments, shortening the length of the stent 1802 on the sideopposite the pressure curve 852 can change the length of the stentwithout changing the position of the stent. In some embodiments, thecorrected pressure ratio curve 1004 can be updated in real time suchthat as the stent 1802 is being shortened, the curve 1004 is adjusted toreflect the predicted pressure ratio with the stent 1802 having thecontemporaneous length. Screen display 2000 of FIG. 20 shows the stent2002 with the modified, shorter length, as well as the modifiedposition, along the pressure ratio curve 852. The data depicted in thescreen display 2000 (FIG. 20) corresponds to the data shown in screendisplay 1900 (FIG. 19).

Screen display 2000 also provides a corrected pressure ratio curve 1004that is updated based on the decreased length of the stent 2002. In theembodiment of FIG. 20, the shortened length of the stent 2002 does notprovide an improvement to the reduced pressure caused by an obstructionin the vessel 702. Indeed, the curve 1004 of FIG. 20 is farther from thetarget line 820 than the curve 1004 of FIG. 16 when the stent 1602 hadits original length. The curve 1004 of FIG. 20 being farther from thetarget line 820 is indicative of that fact that that the stent 2002poorly spans the obstruction in the vessel 702 and is insufficient toremedy the changes in pressure caused by the obstruction. To improve thepredicted pressure ratio within the vessel 702 during PCI planning, aclinician can increase the length of the stent, as described below.

FIG. 21 illustrates a screen display 2100 (or partial screen display)including a visual representation of a vessel. The data depicted in thescreen display 2100 (FIG. 21) corresponds to the data shown in screendisplay 2200 (FIG. 22). In the embodiment of FIG. 21, the screen display2100 is shown to be in an intermediate stage in which the length ofstent 2102 is being increased in response to a corresponding user input.In some embodiments, the user input is the selection of the lengthenoption 1508. Selection of the lengthen option 1508 can cause the lengthof the stent 1702 to be increased by a fixed or variable amount on one,the other, or both of the ends 2106. In some embodiments, such as whenthe user input is received on a touch sensitive display, the user inputcan include a touch on one, the other, or both of the ends 2106 and adrag away from the center of the stent 2102. As a result of the userinput, the stent 2106 can be lengthened by the lengths 2104 on both ends2106 of the stent. As shown in FIG. 21, the end of the stent closer tothe change in pressure ratio (e.g., from 0.93 to 0.81) is lengthenedsuch that the stent covers a region of the vessel 702 that is likely tohave the obstruction causing the pressure change. While the lengths 2104on both ends 2106 are different in FIG. 21, it is understood that thelengths 2104 can be the same in other embodiments. It is also understoodthat that the stent 2106 can be lengthened on only one end 2106. Screendisplay 2300 of FIG. 23 shows the stent 2302 with the modified, longerlength in the vessel 702. The data depicted in the screen display 2300(FIG. 23) corresponds to the data shown in screen display 2400 (FIG.24).

FIG. 22 illustrates a screen display 2200 (or partial screen display)including a visual representation of a pressure ratio. The data depictedin the screen display 2200 (FIG. 22) corresponds to the data shown inscreen display 2100 (FIG. 21). In the embodiment of FIG. 22, the screendisplay 220 is shown to be in an intermediate stage in which the lengthof stent 2202 is being increased in response to a corresponding userinput. In some embodiments, the user input is the selection of thelengthen option 1608. Selection of the lengthen option 1608 can causethe length of the stent 2202 to be increased by a fixed or variableamount on one, the other, or both of the ends 2206. In some embodiments,such as when the user input is received on a touch sensitive display,the user input can include a touch on one, the other, or both of theends 2206 and a drag away from the center of the stent 2202. As a resultof the user input, the stent 2202 can be lengthened by the lengths 2204on both ends 2206 of the stent. In some embodiments, lengthening thestent 2202 adjacent the pressure curve 852 can cause the stent 2202 tomove from the original position of the stent 1602. That is, increasingthe length on the left side of the stent 1602 (in the embodiment of theFIG. 22) results both in the length of the stent changing as well as theposition of the stent moving to the left. In some embodiments,shortening the length of the stent 2202 on the side opposite thepressure curve 852 can change the length of the stent without changingthe position of the stent. As shown in FIG. 22, the stent 2202 islengthened and moved such that the stent covers a region of the curve852 indicative of a pressure change caused by an obstruction in thevessel. While the lengths 2204 on both ends 2206 are different in FIG.22, it is understood that the lengths 2204 can be the same in otherembodiments. It is also understood that that the stent 2206 can belengthened on only one end 2206. In some embodiments, the correctedpressure ratio curve 1004 can be updated in real time such that as thestent 2202 is being lengthened, the curve 1004 is adjusted to reflectthe predicted pressure ratio with the stent 2202 having thecontemporaneous length. Screen display 2400 of FIG. 24 shows the stent2402 with the modified, longer length, as well as the modified position,along the pressure ratio curve 852. The data depicted in the screendisplay 2400 (FIG. 24) corresponds to the data shown in screen display2300 (FIG. 23).

Screen display 2400 also provides a corrected pressure ratio curve 1004that is updated based on the increased length of the stent 2402. Forexample, the curve 1004 of FIG. 24 is closer to the target line 820,compared to the curve 1004 of FIG. 16 when the stent 1602 had itsoriginal length. The curve 1004 of FIG. 24 being closer to the targetline 820 is indicative of that fact that that the stent 2402 is a betterlength relative to an obstruction in the vessel 702 to remedy thechanges in pressure caused by the obstruction. While the curve 1004 isnot above the target line 820, a clinician may make a medicaldetermination during PCI planning that the predicted result is the bestpossible clinical outcome. The virtual/simulated characteristics of thestent 2402 can be correlated to real, physiological parameters of astent to be positioned within the human vessel to treat a patient basedon the PCI planning. Thus, lengthening and shortening the graphicalrepresentation of the stent allows a clinician to choose an appropriatephysiologic length for the stent being deployed to maximize clinicalefficacy during PCI planning.

In some embodiments, changing the length of a stent in the vessel 702 ofthe screen displays 1700 (FIG. 17) and 2100 (FIG. 21) can cause thestent to be correspondingly shortened or lengthened, respectively, alongthe pressure ratio curve 852 of the screen displays 1800 (FIG. 12) and2200 (FIG. 22). Similarly, changing the length of a stent along thepressure ratio curve 852 of the screen displays 1800 (FIG. 12) and 2200(FIG. 22) can cause the stent to be correspondingly shortened orlengthened, respectively, in the vessel 702 of the screen displays 1700(FIG. 17) and 2100 (FIG. 21). In this manner, a clinician can conductPCI planning while interacting directly with a selected one of thescreen displays 1700 and 1800, while automatically viewing correspondingchanges in the unselected one of the screen displays 1700 and 1800.Likewise, a clinician can conduct PCI planning while interactingdirectly with a selected one of the screen displays 2100 and 2200, whileautomatically viewing corresponding changes in the unselected one of thescreen displays 2100 and 2200. For example, a clinician can workdirectly on the screen display 2200 that illustrates the pressure ratiocurve 852 and the length of the stent relative to the calculatedpressure ratio curve. The stent can be lengthened along the pressureratio curve 852 such that the corrected pressure ratio curve 1004 moreclosely matches the ideal pressure ratio line 806 and/or the target line820. A corresponding change in the length of the stent can be made onthe screen display 2100 of the vessel such that a clinician understandsthe length of the stent to be deployed in the vessel to achieve thecorrected pressure ratio curve 852 (FIG. 24).

While the description FIGS. 7-24 describes one modification (e.g.,moving the stent, changing the length of the stent), it is understoodthat multiple operations can be performed on the stent (e.g., one ormore instances of moving the stent and one or more instances of changinglength of the stent).

Further, while the length and position of a stent have been described inthe context of FIGS. 7-24, it is understood that the disclosuresimilarly applies to other characteristics of the stent, such asdiameter and material. For example, physiologic stent sizing can bebased on both lesion length and vessel diameter. For example, a 16 mmstent can have diameters in quarter millimeter increments between 2.5 mmand 5.0 mm. In various embodiments, the diameter of the graphicalrepresentation of the vessel can be selected to appropriately fit withinthe visual representation of the vessel or along the pressure curve. Acomputing device can correlate the diameter of the graphicalrepresentation of the stent to a real physiologic diameter of a stent tobe inserted into a human vessel. In some embodiments, a clinician canmanually input the physiologic stent diameter.

In some embodiments, a computing device can implement QCA (quantitativecoronary angiography) to determine the diameter of the vessel in, e.g.,an angiographic image. For example, during PCI planning, a clinician canselect a position and/or length for a graphical representation of thestent overlaid on the angiographic image of the vessel or a pressurecurve. A computing device, using QCA, can determine the real physiologicvessel diameter at both ends of the proposed stent and determine thephysiologic stent diameter that is recommended for use within the humanvessel. For example, the computing device can select the larger of thetwo diameters associated with both ends of the proposed stent. Aclinician can direct the determination of the physiologic stent diameteror a computing device can automatically determine and provide thephysiologic stent diameter.

In some embodiments, intravascular imaging can be used to determine aphysiologic stent diameter. For example, a vessel can be imaged usingintravascular ultrasound (IVUS), forward looking IVUS (FL-IVUS), opticalcoherence tomography (OCT), and/or other imaging modalities. In thatregard, the methods 500 and 600 can include obtaining intravascularimaging data in some embodiments. The intravascular images can beco-registered with the angiographic data and/or the physiologic data(e.g., pressure measurements, flow measurements, etc.), as described,for example, in U.S. Pat. No. 7,930,014, titled “VASCULAR IMAGECO-REGISTRATION,” which is hereby incorporated by reference in itsentirety. For example, during PCI planning, a clinician can select aposition and/or length for a graphical representation of the stentoverlaid on the angiographic image of the vessel or a pressure curve. Aclinician can view the intravascular images at both ends of the proposedstent and determine the physiologic vessel diameters based on theintravascular images. In some embodiments, a computing device canautomatically determine the vessel borders and physiologic vesseldiameter using intravascular images as described, for example, in U.S.Provisional Application No. 62/024,339, titled “DEVICES, SYSTEMS, ANDMETHODS FOR IMPROVED ACCURACY MODEL OF VESSEL ANATOMY,” and filed Jul.14, 2014, which is hereby incorporated by reference in its entirety.Based on the determined physiologic vessel diameters, a clinician candetermine the physiologic stent diameter or a computing device canautomatically determine and provide the physiologic stent diameter. Forexample, the clinician or computing device can select the larger of thetwo diameters associated with both ends of the proposed stent.

Further, it is understood that PCI planning can include positioning andindividually adjusting more than one stent within the vessel. In thatregard, FIGS. 25 and 26 illustrate screen displaying having multiplegraphical representations of stents. FIG. 25 illustrates screen display2500 (or partial screen display) including a visual representation of avessel having two graphical representations of stents 2502 and 2504.FIG. 26 illustrates a screen display 2600 (or partial screen display) ofa visual representation of a pressure ratio having two graphicalrepresentations of stents 2602 and 2604. The data depicted in the screendisplay 2500 (FIG. 25) corresponds to the data shown in screen display2600 (FIG. 26) and vice versa. PCI planning can include multiplegraphical representations of stents when the angiography and/orphysiologic data indicate multiple occlusions. For example, the pressurecurve 852 of FIG. 26 includes two pressure drops 2610 and 2612 that canbe attributable to distinct lesions. PCI planning can includedetermining to treat one or both of the lesions. While two stents arespecifically referred to in the discussion of FIGS. 25 and 26, it isunderstood that the PCI planning can include any suitable number ofstents, including one, two, three, four, five, six, or more.

As shown in FIG. 25, the graphical representations of the stents 2502and 2504 can each be inserted within the visual representation of thevessel 702. PCI planning can be carried out by moving the graphicalrepresentations of the stents 2502 and 2504, changing thelengths/diameters, etc., as described herein. In some embodiments, thecharacteristics of the graphical representations of the stents 2502 and2504 can individually modified, such as by first receiving a user inputto select a particular stent and then receiving a user input to modifythe characteristics of the selected stent. In some embodiments, thecharacteristics the stents 2502 and 2504 can be inserted and/or modifiedtogether, such as a by first receiving a user input to select bothstents and receiving a user input to modify the characteristics of bothstents.

As shown in FIG. 26, graphical representations of the stents 2602 and2604 can each be inserted along the visual representation of thepressure ratio. PCI planning can be carried out by moving the graphicalrepresentations of the stents 2602 and 2604, changing thelengths/diameters, etc., as described herein. In various embodiments,the characteristics of the graphical representations of the stents 2602and 2604 can individually or collectively modified. A corrected pressureratio curve can be associated with each graphical representation of thestent. For example, the corrected pressure ratio curve 2606 isassociated with the stent 2602, and the corrected pressure ratio curve2604 is associated with the stent 2604. A clinician can insert thegraphical representation of the stent 2602 along the pressure curve 852.The characteristics of the graphical representation of the stent 2602can be modified as described herein. The stent 2602 results in someclinical improvement, as indicated by the distal value of correctedpressure ratio curve 2606 being above the threshold 804. The cliniciancan insert the graphical representation of the stent 2604 along thecorrected pressure ratio curve 2606. The characteristics of thegraphical representation of the stent 2604 can be modified as describedherein. The stent 2604, together with the stent 2602, can result inbeneficial clinical outcomes, as indicated by the distal value of thecorrected pressure ratio curve 2608 being above the target line 820. Thevirtual/simulated characteristics of the stents 2602 and 2606 can becorrelated to real, physiological parameters of the stents to bepositioned within the human vessel to treat a patient based on the PCIplanning.

As described herein, modifying the characteristics of one or both of thegraphical representations of the stents in in the vessel 702 of thescreen displays 2500 (FIG. 25) can cause corresponding the graphicalrepresentation of the stent(s) along the pressure curve(s) of the screendisplay 2600 (FIG. 26) to be similarly modified.

FIG. 27 illustrates a screen display 2700 (or partial screen display)including a visual representation of a vessel. The data depicted in thescreen display 2700 (FIG. 27) corresponds to the data shown in screendisplay 2800 (FIG. 28). The screen display 2700 includes a stent optionsmenu 2704 including a plurality of stents. While three stents are shownin FIG. 27, it is understood that more or fewer stents can be providedin different embodiments. Each of the plurality of stents can havesimilar or different physical characteristics, including length,diameter, material, etc. In some embodiments, the stents provided in themenu 2704 correspond to those available to a clinician in a procedureroom. For example, a computing device (e.g., computing device 172 ofFIG. 4) can access an inventory database of a hospital or otherprocedure location to determine the types of stents that are in stockand available for a clinician to use. In some embodiments, the stentsprovided in the menu 2704 corresponded to those available for purchaseand use from one or more manufacturers. For example, a computing devicecan access an inventory database of one or more manufacturers todetermine the types of stents that are available for a clinician orhospital to purchase and use. The menu 2704 can include visualrepresentations 2706 of the various stents. Stents of differentmaterials and other properties can be indicated by differentcolorizations, shading, patterns, etc. A description 2708 can alsoaccompany each of the stents in the menu 2704. For example, thedescription 2708 can include the length of the stent.

As described above, a user input to insert a stent in the vessel 702 cancause a computing device to automatically determine the recommendedphysical characteristics of the stent. In some instances, therecommended physical characteristics may not correspond to an stent thatis in stock and available for a clinician to use. For example, arecommended physiologic length determined by the computing device may be15.5 mm, while actual stents are only available in increments of 1 mm.Further, the stent can be identified by both the physiologic length andthe physiologic diameter. In such embodiments a computing device canautomatically determine which stent among the available stents mostclosely matches the recommended physical characteristics and provide themost closely matching stent in the vessel 702. For example, a computingdevice may provide a 16 mm long and 3.0 mm diameter stent that is instock and available for a clinician in the vessel 702, when 15.5 mm isthe recommended stent length. The physiologic stent diameter can bedetermined as described herein. In some embodiments, the clinician candetermine and provide the length and/or diameter for the stent to acomputing device. The computing device can access the inventory databaseand recommend suitable stent(s) based on the inputted length and/ordiameter. A user can change the recommended stent by selecting anotheroption from the menu 2704. A user can also modify the characteristics ofthe stent, such as location, diameter, and length, as described above.In some embodiments, the menu 2704 provides only stents that are instock and available, while in other embodiments, menu 2704 provides allstents at a hospital, regardless of whether they are in stock oravailable. An indicator, such as a symbol or coloring, can be disposedadjacent to either those that are available or those that areunavailable to visually distinguish them from the others. In otherembodiments, the computing device does not automatically select fromamong the plurality of stents. Rather, a clinician is able toindividually select from the menu 2704 to determine which stent is mostsuitable. The visual representation of the automatically recommended orclinician selected stent 2702 that is inserted in the vessel 702 can beindicated by highlighting 2710 in the menu 2704. The stent 2702 can bemodified as described in the context of FIGS. 7-24.

FIG. 28 illustrates a screen display 2800 (or partial screen display)including a visual representation of a pressure ratio. The data depictedin the screen display 2800 (FIG. 28) corresponds to the data shown inscreen display 2700 (FIG. 27). The screen display 2800 includes a stentoptions menu 2804 including a plurality of stents. While three stentsare shown in FIG. 28, it is understood that more or fewer stents can beprovided in different embodiments. In some embodiments, the stentsprovided in the menu 2804 correspond to those available to a clinicianin a procedure room. For example, a computing device (e.g., computingdevice 172 of FIG. 4) can access an inventory database of a hospital orother procedure location to determine the types of stents that are instock and available for a clinician to use. In some embodiments, thestents provided in the menu 2804 corresponded to those available forpurchase and use from one or more manufacturers. For example, acomputing device can access an inventory database of one or moremanufacturers to determine the types of stents that are available for aclinician or hospital to purchase and use. The menu 2804 can includevisual representations 2806 of the various stents. Stents of differentmaterials and other properties can be indicated by differentcolorizations, shading, patterns, etc. A description 2808 can alsoaccompany each of the stents in the menu 2804. For example, thedescription 2808 can include the stent length.

As described above, a user input to insert a stent along the pressureratio curve 852 can cause a computing device to automatically determinethe recommended physical characteristics of the stent. In someinstances, the recommended physical characteristics may not correspondto a stent that is in stock and available for a clinician to use. Forexample, a recommend physical length determined by the computing devicemay be 15.5 mm, while stents are only available in increments of 1 mm.Further, the stent can be identified by both the physiologic length andthe physiologic diameter. In some embodiments, the clinician candetermine and provide the length and/or diameter for the stent to acomputing device. The computing device can access the inventory databaseand recommend suitable stent(s) based on the inputted length and/ordiameter. In such embodiments, a computing device can automaticallydetermine which stent among the available stents most closely matchesthe recommended physical characteristics and provided the most closelymatching stent along the curve 852. For example, a computing device mayprovide a 16 mm long and 3.0 mm diameter stent that is in stock andavailable for a clinician along the curve 852, when 15.5 mm is therecommended stent length. The physiologic stent diameter can bedetermined as described herein. A user can change the recommended stentby selecting another option from the menu 2804. A user can also modifythe characteristics of the stent, such as location, diameter, andlength, as described above. In some embodiments, the menu 2804 providesonly stents that are in stock and available, while in other embodiments,menu 2804 provides all stents at a hospital, regardless of whether theyare in stock or available. An indicator, such as a symbol or coloring,can be disposed adjacent to either those that are available or thosethat are unavailable to visually distinguish them from the others. Inother embodiments, the computing device does not automatically selectfrom among the plurality of stents. Rather, a clinician is able toindividually select from the menu 2804 to determine which stent is mostsuitable. The graphical representation of the automatically recommendedor clinician selected stent that is inserted along the curve 852 can beindicated by highlighting 2510 in the menu 2804. The stent 2802 can bemodified as described in the context of FIGS. 7-24.

In some embodiments, inserting a stent from the menu 2704 in the vessel702 of the screen display 2700 (FIG. 27) can cause the stent to becorrespondingly inserted along the pressure ratio curve 852 of thescreen display 2800 (FIG. 28). Similarly, inserting a stent from themenu 2804 along the pressure ratio curve 852 of the screen display 2800(FIG. 28) can cause the stent to be correspondingly inserted in thevessel 702 of the screen display 2700 (FIG. 27). In this manner, aclinician can conduct PCI planning while interacting directly with aselected one of the screen displays 2700 and 2800, while automaticallyviewing corresponding changes in the unselected one of the screendisplays 2700 and 2800. For example, a clinician can work directly onthe screen display 2800 that illustrates the pressure ratio curve 852and the position/length the stent relative to the calculated pressureratio curve. A stent from among the plurality of available stents can beselected and inserted along the pressure ratio curve 852 such that thecorrected pressure ratio curve 1004 more closely matches the idealpressure ratio line 806 and/or the target line 820. A correspondingstent can be inserted in the vessel 702 of the screen display 2700 ofthe vessel such that a clinician understands which of the availablestents should be deployed in the vessel to achieve the correctedpressure ratio curve 1004. In the embodiment of FIG. 2800, a longerstent is necessary to bring the corrected pressure ratio curve 1004closer to the threshold 804.

Persons skilled in the art will also recognize that the apparatus,systems, and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. A system for evaluating a vessel of a patient,comprising: a pressure-sensing device sized and shaped for introductioninto the vessel of the patient; and a processor communicatively coupledto the pressure-sensing device and a display device, the processorconfigured to: receive pressure measurements from the pressure-sensingdevice while the pressure-sensing device is positioned within thevessel; determine a plurality of pressure ratios along a length of thevessel based on the pressure measurements; output, to the displaydevice, a screen display that includes: an image of the vessel; and aplurality of visualizations of the plurality of pressure ratios alongthe length of the vessel in the image; receive a user input to simulatea therapeutic procedure for the vessel; and update the screen display,in response to the user input, to demonstrate a simulated effect of thetherapeutic procedure on the plurality of pressure ratios by modifyingthe plurality of visualizations along the length of the vessel in theimage.
 2. The system of claim 1, wherein the image of the vesselcomprises an angiographic image of the vessel.
 3. The system of claim 1,wherein the plurality of visualizations comprises symbolic indicators ofthe plurality of pressure ratios overlaid on the image of the vessel. 4.The system of claim 1, wherein the processor is configured to update thescreen display by outputting a graphical representation of a stent inthe image.
 5. The system of claim 4, wherein the processor is configuredto update the screen display by adjusting at least one of a length ofthe graphical representation of the stent or a position of the graphicalrepresentation of the stent relative to the vessel in the image of thevessel.
 6. The system of claim 4, wherein the processor is furtherconfigured to determine a length of the stent based on the plurality ofpressure ratios.
 7. The system of claim 1, wherein the processor isconfigured to determine the simulated effect of the therapeuticprocedure based on the plurality of pressure ratios and a parameter ofthe therapeutic procedure.
 8. The system of claim 7, wherein theparameter of the therapeutic procedure comprises at least one of a stentposition, a stent length, or a stent diameter.
 9. The system of claim 7,wherein the processor is configured to update the screen display tooutput a graphical representation of the parameter of the therapeuticprocedure.
 10. The system of claim 1, wherein the screen display furthercomprises a stent placement field, and wherein the user input isgenerated in response to a user interaction with the stent placementfield.
 11. The system of claim 10, wherein the user input indicates aninstruction to modify at least one of a length of a stent associatedwith the simulated therapeutic procedure or a position of the stentrelative to the vessel in the image.
 12. The system of claim 10, whereinthe stent placement field comprises a plurality of graphicalrepresentations of a plurality of differently-sized stents, and whereinthe user input indicates a selection of one stent of the plurality ofdifferently-sized stents.
 13. The system of claim 10, wherein theprocessor is configured to receive the user input by receiving aclick-and-drag input from a user interface device, wherein theclick-and-drag input indicates a placement of a stent from the stentplacement field to a location on the image of the vessel.
 14. The systemof claim 1, wherein the screen display further includes a plurality ofmarkers indicative of a plurality of locations of the vessel associatedwith the plurality of pressure ratios.
 15. The system of claim 14,wherein successive markers of the plurality of markers are positionedalong the vessel in the image at unequally spaced intervals.